Camargo 505(b)(2) Blog

Scope of Orphan Drug Exclusivity – How Broad is Broad?

It has recently been reported that drugmakers have argued against broad orphan exclusivity for Eagle Pharmaceuticals, Inc.’s Bendeka® product. This was in response to the FDA’s invitation to applicants of certain products containing bendamustine to share how broad of a scope they believe Eagle’s seven-year orphan drug exclusivity for Bendeka should be, and if it […]
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Market Assessment: Is Your Product Going To Make It On The Market?

A lot of our focus in previous blogs has been on how to best negotiate regulatory hurdles to get your product approved as quickly and cheaply as possible, and how to differentiate your product from the marketed products. And as we have previously blogged, to get a successful return on investment (ROI) for your product, […]
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“Breakthrough” the Barriers: Breakthrough Therapy Designation for 505(b)(2)

“Breakthrough” the Barriers: Breakthrough Therapy Designation Will Speed Up the Development and Review Time for Your 505(b)(2) Product Breakthrough Therapy Designation (BTD) is the most recent addition to the suite of expedited programs offered by the FDA. In comparison to Fast Track Designation (discussed in a prior blog), the qualifying criteria for BTD are more […]
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FDA Firsts and Updates: Competitive Generics, Complex Generics, SiRNA approval, and Closing the Orphan Loophole

We decided to mention some noteworthy firsts from the FDA during August 2018 and a change in the FDA’s policy on obtaining orphan incentives via pediatric-subpopulation designation. Competitive Generic Therapy Designation The FDA granted Competitive Generic Therapy (CGT) designation for the first time for Potassium Chloride oral solution (ANDA 211067; Apotex, Inc; approved 8 August […]
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GDUFA I and II: Considerations for Complex Generics Innovators

The increasing complexity of brand-name drugs has made development of generic alternatives more challenging as well. As complex generic drug products can provide a high-value opportunity for drug development companies, they are similar to 505(b)(2) products in that they may require early and flexible interaction with the FDA. The same expertise Camargo holds in developing […]
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505(b)(2) Nonclinical Development: Examples and Advantages

The 505(b)(2) New Drug Application (NDA) pathway can provide unique advantages from the nonclinical development perspective that can save significant amounts of time, money, and resources. Compared to the 505(b)(1) NDA pathway, which is more standardized and follows the general guidance provided by the International Conference on Harmonization (ICH) M3[1], the nonclinical development program under […]
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Innovative Thinkers: FDA wants YOU

New FDA Guidance on OTC Products FDA just released a very brief (barely three pages of actual text) guidance promoting innovation in new drug applications (NDAs) involving nonprescription (aka over-the-counter, OTC) drug products. In the guidance, “Innovative Approaches for Nonprescription Drug Products, Guidance for Industry’ (CDER July 2018) FDA describes “…two innovative approaches that may […]
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The Importance of the Target Product Profile in 505(b)(2) Development

The Importance of the Target Product Profile in 505(b)(2) Development Camargo co-founders, Dr. Ruth Stevens, Chief Scientific Officer and Executive Vice President, and Ken Phelps, President, discuss an important question Camargo often hears from prospective clients: What does the Target Product Profile have to do with the development program for my 505(b)(2) Project? Read the […]
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Nonclinical Study Requirements for 505(b)(2) Development

On June 1, 2018, Camargo Pharmaceutical Services celebrated our 15th Anniversary. For this week’s blog, Camargo co-founders, Dr. Ruth Stevens, Chief Scientific Officer and Executive Vice President, and Ken Phelps, President, discuss an important question Camargo often hears from prospective clients: What Nonclinical Study Requirements Do I Have for my 505(b)(2) Drug Development Project?   […]
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What Clinical Studies Are Needed for a 505(b)(2) Drug Development Project?

On June 1, 2018, Camargo Pharmaceutical Services celebrated our 15th Anniversary. For this week’s blog, Camargo co-founders, Dr. Ruth Stevens, Chief Scientific Officer and Executive Vice President, and Ken Phelps, President, discuss an important question Camargo often hears from prospective clients: What Clinical Studies Do I Need to Run for my 505(b)(2) Drug Development Project? […]
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Europe’s Value Added Medicines Initiative

The European Union (E.U.) and the United States (U.S.) both have regulations that allow existing drugs to be improved. The E.U. pathway is limited to improvements of drugs that were approved in the E.U. and that are now generic. Readers of this blog are familiar with the U.S. 505(b)(2) pathway that is not restricted to […]
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Complete Response Letters (CRLs): Big Trouble for Small Pharma

A Complete Response Letter (CRL) can have a devastating effect on a small company’s share value, as evidenced by the recent examples of Recro Pharma and Cosmo Pharmaceuticals. A recent EP Vantage analysis of publicly-reported Complete Response Letters (CRLs) issued by the FDA from 1 January 2017 until 30 May 2018 had surprising results. The […]
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Getting Liposome Drug Products Approved: They Are Non-biological Complex Drugs

Liposome drug products frequently contain an already-approved drug, and can utilize the 505(b)(2) pathway to approval. Liposomal drug products are a sub-group of Non-biological Complex Drugs (NBCD) and contain greater complexity in characterization and approval than small-molecule drugs. Further, their generic follow-on products, ‘nanosimilars’ or complex generics, require more studies and/or more complicated studies to […]
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New FDA Guidance Illustrates Breadth of 505(b)(2) Development Programs

It is clear the FDA recognizes the range of development possibilities made possible by the 505(b)(2) pathway, as illustrated by the recently released draft guidance for the development of depot buprenorphine products for treatment of opioid-use disorder. What is striking about this guidance is that it attempts to address all possible approaches to achieving the […]
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FDA Action on Exparel® Highlights the Importance of Letting the Data Drive the Story

The recent key decision by the FDA for Exparel® stresses the importance of reevaluating 505(b)(2) strategy throughout a product development lifecycle. A solid, data-driven development strategy is important from the beginning; however, new data, including related regulatory actions, must be considered and incorporated to realign the program throughout development to achieve success in the end. […]
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505(b)(1) versus 505(b)(2): They Are Not the Same

The 505(b)(2) pathway can yield significant benefits in drug development cost and time. But what are the differences in 505(b)(1) versus 505(b)(2)? They are not the same. Drug development pathways in the United States are referred to by their corresponding section in the Food, Drug, and Cosmetics Act: 505(b)(1), 505(b)(2), and 505(j). There are other […]
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Exclusivity GAINs Additional Indications: Advantages of QIDP Designation Paired with 505(b)(2) Strategy

Additional Indications: Advantages of QIDP Designation The benefits of early strategy for 505(b)(2) drug development programs are numerous, but none as substantial as market exclusivity. Incentives available to sponsors of QIDP include fast track designation, priority review designation, and 5 years of additional market exclusivity. A recently updated FDA guidance for U.S. antibiotic and antifungal […]
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How to Get Orphan Status for 505(b)(2) Drugs

2017 was a big year for orphan designations and approvals. Sixteen of the sixty-three (25%) products approved via the 505(b)(2) pathway in 2017 received orphan designation. Importantly, more than half of the approved 505(b)(2) products with orphan designation received seven years of orphan exclusivity. That’s not bad when you consider that 505(b)(2) drugs are often […]
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Product Ideation: Who Wants to Develop a Successful Product?

As Sponsors become more aware of the benefits and risks of developing products in the current market, their focus often turns to Product Ideation and how this process can help develop smarter products. The growing interest in this service led Ken Phelps, CEO of Camargo, to provide a webinar on this topic for Sponsors. Here […]
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Why You Need Camargo’s Cutting-Edge Pharmacokinetics Team Involved In Your 505(b)(2) Program: Can We Really Do That?

If you think regulatory pharmacokinetics requirements are just a box-checking exercise then you may be throwing away money and time on unnecessary studies. At Camargo, we have always focused on innovative approaches for the most challenging drug development programs, but our cutting-edge pharmacokinetics strategies are getting attention from industry, academia, and the FDA. We have […]
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Key Questions You Must Ask Before Hiring a Drug Development Consultant

Drug development consultants worldwide promise many things. Traditionally, biotech and pharma companies hire consultants to help guide them through the regulatory process or to fill in where their own companies have a lack of knowledge or resources, but many consultants can do much more than regulatory. There are several key questions you should ask before […]
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Two Investigational Applications for One Drug Product? IVD Device Requirements

A New Draft Guidance Provides In Vitro Diagnostic Device Requirements That May Impact Therapeutic Drug Trials Did you know that an assay used in a clinical trial designed to study an investigational drug may be considered an investigational In Vitro Diagnostic (IVD) Device, and therefore subject to the requirements of an Investigational Device Exemption (IDE)? […]
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2017 – A Great Year for Generics – Yes or No?

Generic Firms Looking for Revenue with 505(b)(2) AAM’s Annual Conference is over and most of the generic companies are glad 2017 is over, too. Despite media reports that 2017 was the best year ever for generics, only 3 companies of the top 30 companies reported a profit. This discrepancy can be found in the point […]
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Increase the Value of your Prodrug Asset Under 505(b)(2): An Alkermes Program Update

A prodrug developed via the 505(b)(2) pathway can improve an existing therapeutic while increasing the value of the asset. The therapeutics which excite us most here at Camargo are drugs which deliver effective therapies to patients in need, including therapies improved by utilizing prodrugs. While not all prodrugs are eligible for development via the 505(b)(2) […]
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505(b)(2) Approvals for 2017: What Were They and Who Developed Them?

Our last blog gave the numbers on 505(b)(2) approvals in 2017, including orphan designations and priority review products. Here we take an in-depth look at what kind of products were approved via the 505(b)(2) pathway, and under which therapeutic areas and FDA Review Divisions they fell. We look at their review commitments, and at the […]
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505(b)(2) Success Requires More Than Just Science

At the JP Morgan Conference/Biotech Showcase this year, we encountered a record number of companies engaged in 505(b)(2) development. We also had meetings with investors and buyers with their checkbooks open to finance or acquire the more than 80 products we have in development. Unfortunately, many of our clients are not ready for this money. […]
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Chemistry, Manufacturing, and Controls Requirements: Bridging and 505(b)(2)

One of the main causes of Refusal to File / Receive actions by the US FDA is due to inadequate Chemistry, Manufacturing, and Controls (CMC) data. This missing data relates to formulation issues, incomplete stability data, and inactive ingredients listed above the limits found in the Inactive Ingredients Database without appropriate supportive data. A drug […]
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Rx-to-OTC Switch: Expanding to the US Over-the-Counter Market

Changing the marketing status of a drug from prescription (Rx) to over-the-counter (OTC), known as an Rx-to-OTC switch, can increase drug utilization by an average of 30% (Stomberg et al. 2013). According to the Consumer Healthcare Products Association (CHPA), more than 700 current OTC products contain drugs or dosages that were available only by prescription […]
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Get Your Pre-IND Meeting Done Right the First Time, and Other FDA Words of Wisdom

While the old adage “It’s easier to beg forgiveness than to ask permission” might have worked well as a child, it rarely applies when dealing with the FDA. The FDA recently published a final guidance titled “Formal Dispute Resolution: Sponsor Appeals Above the Division Level”, which outlines procedures for resolving scientific and medical disputes between […]
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Complex Generic Drug Products: A Changing Regulatory Landscape

Earlier this year, the U.S. Food and Drug Administration (FDA) announced its Drug Competition Action Plan, which aims to bring more competition to the drug market and improve consumer access to drugs. As part of this effort, the Agency is focusing on ways to help bring complex generic drugs to market, providing competition to this […]
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Gaining New Indications With Real World Data: The 505(b)(2) Sweet Spot

Gaining approval of new indications for approved or “old” drugs has always been one of the great advantages of the 505(b)(2) regulatory pathway. Couple that with the FDA’s recent enthusiasm for using real world evidence (RWE) to expand a drug’s indications, and you have a strong incentive to get new indications approved particularly, but not […]
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Not a Generic? Must Be a 505(b)(2)?

Generic or 505(b)(2)? The Office of Generic Drugs (OGD) receives many applications under 505(j) that do not meet the statutory definition of a generic drug. The applications reference an approved drug (the referenced listed drug) but differences in formulation, labeling, or other factors cause OGD to recommend that the application be submitted under 505(b)(2). OGD […]
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Drug or Device? – FDA Provides More Clarity – Or Does It?

Drug or Device? – FDA provides more clarity – or does it? Industry has complained for years, and for good reasons, that it is difficult to understand FDA’s determination of whether a combination product would be reviewed as a device or a drug. So, in response to the signing into law of Section 3038 of […]
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Product Selection: Which Product to Develop?

Product Selection and the Importance of Early Strategic Design for Success Why do some new drug products gain approval, but launch with lower-than-anticipated drug sales? Why then can some drug products gain approval and launch and perform well commercially? Is it possible to align a new drug product candidate for success at launch? At Camargo, […]
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Seamless Clinical Trials: Why Didn’t We Think of That?

Seamless clinical trials have become the new buzz word in drug development since FDA Commissioner Scott Gottlieb promoted their use this month. But are they new, and which products are best suited to this style of clinical trial? Oncology drugs are the obvious examples of products that are well suited to the adaptive design of […]
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The Race to Get a Cannabidiol Product Approved: Why Is It Taking So Long?

Several companies have been competing to get the first cannabidiol product to market. Both investor and patient interest are high but the recent news includes more setbacks. What is different about cannabidiol (CBD) products and what could Zynerba Pharmaceuticals, Inc. have done differently? The Cannabidiol Pipeline As we have previously blogged, there are currently no […]
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Navigating Clinical Holds

Sponsors spend countless hours developing Investigational New Drug (IND) applications, which are the US FDA’s regulatory gateways for conducting clinical trials of investigational drug and drug-device combination products. The stakes are high for companies as they submit their initial IND, as the ability to start clinical trials hinges on the activation of the IND. But […]
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De-risking Drug Development

High-level Reasoning and Technical Methodology for Evaluating a Program’s Risk From a distance, 505(b)(2) product development can seem very straightforward for products that have been on the market or in clinical use for long periods of time. However, these types of products can often present the greatest challenges when trying to modify or improve performance. […]
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Stability Requirements in the 505(b)(2) Space: Why, What, When, How

Stability Requirements in the 505(b)(2) Space: Why, What, When, How Hurry up and wait. That’s the seemingly eternal impact of developmental stability on the new drug development process. The question always asked is: “How can the developer minimize the wait part?” At the top level you can’t. It will always take six months to get […]
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Deuterization: Is it Enough to Get 5- or 7-Year Exclusivity for a 505(b)(2) Product?

Deuterization: Is it Enough to Get 5- or 7-Year Exclusivity for a 505(b)(2) Product? As the 505(b)(2) experts, Camargo has received several enquiries about developing deuterated drugs as a means of achieving sustained-release properties for a product. The approval of Austedo (deutetrabenazine; Teva Pharmaceuticals, Inc.; NDA 208082), marked the first FDA approval of a deuterated […]
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What Went Wrong? Make Sure Your Bridge Stays Intact, CMC and Dissolution

Make Sure Your Bridge Stays Intact: CMC and Dissolution in 505(b)(2) Development One of the most common reasons for a company developing a drug to receive a Refuse to File letter from the FDA is for problems with Chemistry, Manufacturing, and Controls (CMC). Camargo has a robust in-house CMC team to help address and prevent […]
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Camargo Counsel: The New Reality of Generics under GDUFA

How to Navigate the Impact of GDUFA From recent news, we know that the FDA has been under increasing pressure to reduce the timing of its reviews while maintaining the highest possible standards for safety and efficacy of the products it approves. This is the reason for the PDUFA and now the GDUFA goals. FDANews.com […]
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PREA Requirements for Biosimilar and Interchangeable Biological Products

In general, under the Pediatric Research Equity Act (PREA), submission of an initial pediatric study plan (iPSP) is required for a drug or biological product that includes a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration. Submission of an iPSP is required 60 calendar days after the […]
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Brexit and EMA: The Changes Have Begun

After months of speculation, the first round of changes for pharmaceutical manufacturers arising from the planned withdrawal of the United Kingdom of Great Britain and Northern Ireland (UK) from the European Union (EU) have arrived. And the changes are major for companies based in the UK that currently market or plan to market centrally authorised […]
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What Went Wrong? Important Outcomes of a Successful Pre-IND Meeting

We are pleased to present the second episode in a new format and series we’re adding to our 505(b)(2) Blog: a video blog / podcast called What Went Wrong? For our second episode, Ken Phelps, CEO, and Dr. Ruth Stevens, CSO, Camargo Pharmaceutical Services, discuss important outcomes for a successful Pre-IND meeting, which is essential […]
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Due Diligence Assessment: Determining a Drug Product’s Potential Value

Due Diligence Assessment: Determining a Drug Product’s Value The risk involved with an asset needs to be assessed before a sale. Whether from the buy or from the sell side, it pays to understand how much an asset is worth. For those involved with in-licensing or out-licensing, a properly performed Due Diligence Assessment places a […]
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The Value of a Strategic Assessment: Aligning for Success from the Start

The Value of a Strategic Assessment The first step for every wise drug developer beginning a drug development program is to determine the feasibility of a proposed product by asking several high-level questions: Is the product scientifically, medically, and commercially viable? What are the regulatory requirements and potential hurdles? What nonclinical and/or clinical studies will […]
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Abuse-Deterrent Opioids – The Insider’s Guide to Innovation and Exclusivity in a Changing Regulatory Landscape

Abuse-Deterrent Opioids – The Insider’s Guide to Innovation and Exclusivity in a Changing Regulatory Landscape As discussed in a previous blog post (here), the 505(b)(2) development pathway provides a flexible path for developers of new abuse-deterrent formulations. The FDA has shown significant motivation and flexibility in its drive to work with innovators to address the […]
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Special Protocol Assessment: Is It Important for Your Drug Development Program?

The overarching goal of the Special Protocol Assessment Draft Guidance for Industry May 2016 (HHS, FDA, CDER, & CBER) is to improve the quality of new drug applications (NDAs) and biologic license applications (BLAs) by providing more certainty in the clinical protocol design process. Among its several purposes, the Special Protocol Assessment (SPA) affords an […]
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Getting Cannabis-related Products Approved: the 505(b)(2) 4-20 Projects

Several states in the US have already passed laws that remove state restrictions on the medical use of marijuana and its derivatives, and more states are considering such action. The market for medical marijuana in the US is expected to surpass $20 billion by 2020. However, federal restrictions prevent the use of medical marijuana as […]
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Shortening the Review Clock: the Latest on Priority Review Vouchers

The Latest on Priority Review Vouchers Priority review vouchers (PRVs) are a valuable incentive available to companies upon approval of novel drugs to treat rare pediatric diseases or certain tropical diseases. These vouchers can be used on a subsequent application to speed the review process and are an asset that can be sold or transferred […]
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DESI Drugs: Potential Targets for Quick Approvals

DESI Drugs: potential targets for quick approvals Drugs that are on the market but are not approved by the FDA are more common than you might think. Even some physicians might be unaware that the drug they are prescribing has not been approved, meaning it has not undergone the rigorous standards of safety and efficacy […]
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Fixed-Dose Combination Products – Navigating the Combination Rule

Fixed-dose combination products (FDCs), or drugs containing multiple active ingredients, offer benefits to pharmaceutical companies and patients. For Pharma, creative matching of multiple APIs can open new markets, while for patients, FDCs can offer convenience and therapeutic benefits. Often, FDCs are composed of previously approved agents, and the 505(b)(2) pathway is commonly used for these […]
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505(b)(2) Approval Times: The Real Scoop

The Approval Time for 505(b)(2) and 505(b)(1) NME Products Is Similar A recent article by the Tufts Center for the Study of Drug Development (summarized here) reported that approval times for New Molecular Entities (NMEs) approved via the 505(b)(2) pathway are nearly 5 months longer than that of NMEs approved by other pathways, 505(b)(1), or […]
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Pre-IND Meetings: How to Achieve Success for 505(b)(2)

One of the greatest mistakes that the Sponsor of a 505(b)(2) can make is to have an unsuccessful Pre-IND meeting. Common errors occur at the Pre-IND meeting because Sponsors and CROs that are more familiar with traditional 505(b)(1) drug development programs fail to appreciate the different goals and the impact of a Pre-IND meeting on […]
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Camargo Counsel: The Cost of Wrong

Here at the Camargo 505(b)(2) blog, we are adding a new voice to mix in with the technical writing. These candid takes will be given by our experts in drug development and sprinkled in with the usual fare. Camargo Counsel is a venue for straightforward talk and advice related to drug development and 505(b)(2). With […]
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Demystifying Orange Book Designations: The New Referencing Approved Drug Products in ANDA Submissions Draft Guidance

Demystifying Orange Book Designations Since its first appearance in 1980, the Approved Drug Products With Therapeutic Equivalence Evaluations publication (commonly referred to as the Orange Book) has served as a gateway for the emergence of generic drug products via the 505(j) drug approval pathway (and some new drug products submitted through the 505(b)(2) approval pathway). […]
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Referencing a Listed Drug for the 505(b)(2) Pathway

Section 505(b)(2) of the Food, Drug, and Cosmetic Act describes a 505(b)(2) new drug application (NDA) as an application where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference. This type of information […]
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Clinical Trials With Multiple Endpoints: Pitfalls and Management

Randomized controlled Phase 3 (and some Phase 2) studies are clinical trials that are designed to answer specific questions, such as whether the proposed drug is effective in treatment or prevention of a particular disease. As such, the primary endpoint is the most important one that will demonstrate the primary effects being sought by the […]
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Real-World Evidence: Can it Really Be Used For Drug Approvals?

With the signing of the 21st Century Cures Act, the US Congress tasked the FDA with developing a framework to evaluate how the use of data from sources other than traditional clinical trials may be used to support drug approvals. This framework will apply to post-market commitments and to new indications for approved drugs. This […]
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Electronic Submissions Update: End of FDA Paper Submissions Looms and What It Means

Electronic Submissions Update: the end of paper submissions looms closer, and requirements for Standardized Study Data go into effect: What that means for industry Under section 745A(a) of the FD&C Act, no earlier than 24 months after FDA issued the final guidance on December 2014, “Providing Regulatory Submissions in Electronic Format – Submissions Under Section […]
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Unforced Errors: FDA Refusal to File or Receive Letters

UNFORCED ERRORS: FDA Refusal to File or Receive Letters Few things can be more damaging to a pharmaceutical company than the refusal by the Food and Drug Administration (FDA) to review their New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). When a company submits their application for authorization to market a new or […]
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On the Rise: 2016 505(b)(2) NDA Approvals

On the Rise: 2016 505(b)(2) NDA Approvals The total number of novel drug approvals in 2016 decreased by approximately half from last year (22 in 2016, from 45 in 2015) and is below the 10-year average of 29 drug approvals per year. Of these, how many were 505(b)(2)s? Were the number of 505(b)(2) approvals in […]
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Improvements and Updates to the FDA Inactive Ingredient Database

Improvements and Updates to the FDA Inactive Ingredient Database The FDA recently announced it has made corrections, updates, and additions of a backlog of formulations to the Inactive Ingredient Database (IID), an important modification for drug developers and development. The previous state of the IID had become an issue as excipient suppliers recommend the use […]
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Improving NDA Approval Odds for New Dosage Forms of Approved Products

Improving NDA Approval Odds for New Dosage Forms of Approved Products There are numerous reasons why a Sponsor may wish to market a new dosage form of an approved product. Aside from the obvious financial benefits to the sponsor, providing a more convenient and/or faster-acting dosage form of a well-chosen drug provides significant benefits for […]
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A New Indication for an Old Drug. What Could Go Wrong?

A New Indication for an Old Drug. What Could Go Wrong? Desmopressin (DDAVP®; Ferring Pharmaceuticals Inc) was approved in the US in 1978. DDAVP is currently approved to treat central diabetes insipidus, hemophilia A, type 1 von Willebrand’s disease, nocturnal enuresis (bedwetting) in children, and as a diagnostic test to measure renal concentrating abilities. Desmopressin […]
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Dramatically Decrease Drug Development Costs Through Literature-Only 505(b)(2) NDA Submissions

Dramatically Decrease Drug Development Costs Through Literature-Only 505(b)(2) NDA Submissions How would you like to get an NDA approved without conducting any clinical studies? Camargo presented a poster on literature-only 505(b)(2) New Drug Application (NDA) approvals at the recent 2016 AAPS annual meeting and exposition in Denver, Colorado. Individuals from the FDA and the pharmaceutical […]
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PRO-CTCAE: Improving Oncology Drug Development

Patient-reported outcomes (PROs) provide valuable tools for collecting information on subjective symptomatic effects during clinical trials. They are considered the gold standard for the assessment of health-related quality of life, treatment preferences, and satisfaction with care. PRO results from a well-defined and reliable PRO instrument can be used to support claims in product labeling, which […]
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Expedited Approval of FDA-approved Drugs in Australia

Expedited Approval of FDA-approved drugs in Australia: New Market Opportunities for Drugs and Devices In the past, after gaining approval for a drug/device in the United States, subsequent approval in Australia involved significant duplicated effort and additional regulatory hurdles. This has resulted in a lack of incentive for pharmaceutical companies and delays of up to […]
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505(b)(2) Application Changes: What You Need to Know

505(b)(2) Application Changes: What You Need to Know Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003 was enacted in order to address concerns that had potential to delay access to more affordable drugs. The FDA has been implementing the MMA via the statute since it was enacted in 2003. […]
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How Many FDA Premarket Applications Are Necessary For Your Combination Product?

This week, we are pleased to share an article written by Camargo Pharmaceutical Services’ new Medical Device expert, Dr. Girish Kumar, along with Dr. P.K. Narang, and published by Pharmaceutical Online, Med Device Online, and Bio Process Online. How Many FDA Premarket Applications Are Necessary For Your Combination Product? Often, an already-approved drug can further […]
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Extrapolation of Clinical Data for Pediatric Uses: Application for Medical Devices and Drug Products

Extrapolation of Clinical Data for Pediatric Uses: Application for Medical Devices and for Drug Products Extrapolation of Clinical Data for Medical Devices1 The Food and Drug Administration released the revised draft guidance entitled ‘‘Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices” on June 21, 2016 (Docket No. FDA–2015–D–1376). This guidance explains […]
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Importing Investigational Pharmaceuticals to the U.S.? Changes Are Coming

Importing Investigational Pharmaceuticals to the U.S.? Changes Are Coming The United States government is making ongoing, concerted efforts to improve the importation process for many products, including pharmaceuticals and medical devices. It’s important to stay on top of the new importation changes and their effect on business. Foreign biotech, device manufacturers, API producers, and pharmaceutical […]
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Risk Evaluation and Mitigation Strategies (REMS) Basics

The Food and Drug Administration is responsible for ensuring that human drugs are safe and effective, while also advancing public health by helping to speed product innovations. In determining if a drug should be marketed, the Agency must weigh the benefits of the therapy against its potential risks to the patient. If a drug or […]
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Effects on Exclusivity: The Biologics Price Competition and Innovation Act of 2009

On March 23, 2010, the U.S. FDA enacted the Biologics Price Competition and Innovation Act of 2009 (BPCIA) as part of the Patient Protection and Affordable Care Act (Public Law 111-148). The passing of BPCIA amended the definition of a “biological product” to include a “protein (except any chemically synthesized polypeptide)”, altering the way that […]
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Improving Drug Development ROI in 2017

Time to Pick the Low-Hanging Fruit: Improving Drug Development ROI in 2017 With forecasts of decreasing peak sales for late pipeline drugs, a logical way to increase the return on investment (ROI) for pharmaceutical companies is to develop products with lower research and development (R&D) costs. How can this be achieved in an environment with […]
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Leveraging Postmarketing Safety Data in 505(b)(2) Drug Development Programs

A significant part of the FDA’s charge is ensuring the safety of drugs available to the public. While a substantial part of the FDA’s efforts in guaranteeing public safety go into the safety assessment process during drug development, the process does not end with NDA approval. Postmarketing assessments such as pharmacovigilance programs play a critical […]
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Orphan Drug Development: Ensuring Best Time to Market

The Benefits of 505(b)(2) for Orphan Drug Development The Orphan Drug Designation Program, created by the Orphan Drug Act of 1983, provides significant financial incentives for the development of drugs for rare diseases. The potential incentives include tax credits for clinical trial costs, waiver of the Prescription Drug User Fee for NDA filing (~$2.4 million […]
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Pitfalls of Changing the Salt of a Listed Drug

Pitfalls of Changing the Salt of a Listed Drug The 505(b)(2) registration pathway for new drug products allows the applicant of the new drug product to reference the literature and the FDA’s findings of safety and/or effectiveness (e.g., as listed on the Listed Drug product’s label) to fulfill various registration requirements. From a nonclinical perspective, […]
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