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Regulatory Strategy & Submissions Articles and Insights

Patient-Centered Drug Development for Oncology Products

Oncology patients face a difficult journey — a frightening diagnosis followed by intricate and oftentimes burdensome treatment regimens with uncertain outcomes. One patient struggles to take the correct dosage at the prescribed times through the “brain fog” caused by his cancer. Another’s livelihood is at

What to Expect from the FDA During COVID-19 Product Development

As the COVID-19 national emergency stretches on in the United States, the eyes of the pharmaceutical industry are trained on developing diagnostic, therapeutic, and preventive measures to combat the novel disease. Given the significance of the pandemic and the critical need, the FDA has developed

Three Keys to Preparing Effective Pre-IND Meeting Questions

Asking the appropriate questions during a Pre-IND meeting with the FDA is a critical step in planning a development program. A Pre-Investigational New Drug Application (Pre-IND) meeting can be a valuable component in planning a development program. For companies that have not previously interacted with

The Shutdown From Camargo’s Perspective

Now that the FDA has received at least a temporary reprieve from the longest government shutdown in history, we thought we would share some background and a timeline, along with our experience during the shutdown. Most months, Camargo meets with the FDA at least 4

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

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

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’

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

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

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,

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

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

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

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

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

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

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

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

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

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

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

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

Abuse Deterrence Labeling – Generic vs 505(b)(2) Drug Development

Abuse Deterrence Labeling – Generic vs 505(b)(2) Drug Development With the ongoing opioid epidemic, drug abuse, diversion, and misuse are significant concerns for the FDA. The current opioid abuse problems also present significant opportunities for companies willing to explore new formulation technologies to deter abuse.

The New FDA Draft Guidance on Chewables

An idea for a more convenient dosage form for an existing drug product often presents an opportunity for a commercial advantage. Fortuitously, it also presents the possibility for using the 505(b)(2) regulatory pathway to product approval, which is often faster and less expensive than the

The GRAS Is Not Always Greener

  The GRAS Is Not Always Greener: Why GRAS Status Does Not Guarantee Excipient Safety Many, if not most, 505(b)(2) submissions represent a change to an approved drug, usually involving a formulation change. Understandably, the focus of sponsors is often primarily on supporting the safety

Back to Basics: 505(b)(2) FAQs Part 3: Regulatory Strategies

As the 505(b)(2) expert, Camargo is frequently asked questions about how to get a product approved via the 505(b)(2) regulatory pathway and if this pathway is appropriate. Given the growing popularity of the 505(b)(2) pathway for approval of repurposed, reformulated, or unapproved-marketed products, we thought

The Regulation of Follow-On Biological Products via 505(b)(2)

Strike While the Iron is Hot In December 2015, the U.S. FDA granted approval for Eli Lilly and Company’s Basaglar (insulin glargine injection), a long-acting human insulin product indicated for glycemic control in patients with diabetes mellitus. Basaglar marked the first “follow-on” insulin therapy to

Pediatric Applicability or Not–This Revised Guidance Is for You

Since 1994, the statutory and regulatory requirements for drug product labeling for pediatric populations have been evolving. The FDA Modernization Act of 1997 (FDAMA) contained incentives for conducting pediatric studies on drugs that had exclusivity or patent protection. In 2003, the Pediatric Research Equity Act

Enforcement Activities: FDA removes unapproved prescription ear drops

For years FDA has threatened to remove unapproved products (so-called DESI products) from the marketplace. Recently, the FDA took enforcement action against  several unapproved prescription ear drops.  What products will be next?  DESI producers can use the 505(b)(2) pathway to avoid such actions on their products. Let's take a