505(b)(2) Patent & Marketing Exclusivity
IP attorney Stephen Albainy-Jenai and I just concluded a webinar hosted by DIA entitled 505(b)(2) Patent…
Results for "marketing exclusivity"
Scope of Orphan Drug Exclusivity – How Broad is Broad?
It has recently been reported that drugmakers have argued against broad orphan exclusivity for Eagle…
Orphan Exclusivity for ‘Same Drug’: What Has Changed Since FDARA 2017/ PDUFA VI?
Last month the US District Court for the District of Columbia ordered the FDA to…
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…
A 505(b)(2) Qualified Infectious Disease Product QIDP Designation – 8 Years of Exclusivity
A 505(b)(2) with 8 years of exclusivity. That is the prize that Calla Therapeutics will…
Deuterization: Is it Enough to Get 5- or 7-Year Exclusivity for a 505(b)(2) Product?
As the 505(b)(2) experts, Premier Consulting has received several enquiries about developing deuterated drugs as…
3-Year Exclusivity May Not Be Worth as Much as You Think
It is a widely held tenet that market exclusivity is essential for the successful launch…
Orphan Drug Exclusivity for a Previously Approved Drug: a 505(b)(2) Conundrum
Until now, if a Sponsor intended to request orphan designation with 7 years of marketing…
Expertise with the 505(b)(2) Development Pathway
The 505(b)(2) Development Pathway A Seamless Connection from Consulting to Clinical The 505(b)(2) New Drug...
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Strategies for Recovering from an Unsatisfactory Pre-IND Meeting
Premier Consulting’s regulatory strategists specializing in the US FDA’s 505(b)(2) approval pathway are often asked…
Why More Drugs Than Ever Are Approved Through 505(b)(2)
Why More Drugs Than Ever Are Approved Through 505(b)(2) Bringing a modified version of an...
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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…
2020 505(b)(2) NDA Approvals: A Year in Review, and What a Year It Was!
In 2020, CDER approved 68 NDAs that used the 505(b)(2) pathway, representing important advances in…
Prescription Digital Therapeutics: When Software Is the Active Ingredient
With smartphones now ubiquitous, interest has increased in digital health solutions such as telemedicine platforms…
COVID-19 Stimulus Legislation Will Cost OTC Manufacturers
Tucked away in the nearly 900 pages of the Coronavirus Aid, Relief, and Economic Security (CARES)…
2019 505(b)(2) NDA Approvals in Review
In 2019, CDER approved 64 NDAs that used the 505(b)(2) pathway, representing important advances in…
Rare and Orphan Drug Development in the EU
A pharmaceutical company is granted orphan designation for a medicine that treats Hunter Syndrome. The…
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…
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%)…
Product Ideation: Who Wants to Develop a Successful Product?
As Sponsors become more aware of the benefits and risks of developing products in the…
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…
Back to Basics: 505(b)(2) FAQs Part 3: Regulatory Strategies
As the 505(b)(2) expert, Premier Consulting is frequently asked questions about how to get a…
Opportunities in Orphan Drug Development for Investors, Pharma, and CROs
Orphan drugs, defined in the Orphan Drug Act as drugs developed to treat rare diseases…
Paragraph IV Certifications under 505(b)(2)
What is the difference between a Paragraph IV certification between the 505j (ANDA, generic) and…
US FDA 505(b)(2) NDA clinical, CMC and regulatory strategy concepts to expedite drug development
May 15, 2023 William Salminen, PhD, DABT, PMP, VP, Nonclinical Safety and Toxicology Olu Aloba,…
Orphan Drug Designation: When Is It Appropriate, and How Does It Apply to Orphan Subsets?
It is an unfortunate reality that many diseases and conditions affect such small numbers of…
Product Development Checklist
Considerations for Each Stage of the Drug Development Process Developing a new biopharmaceutical product is…
FDA Designations for Rare Disease Products, Part 2: Orphan Drug Designation
This is the second installment in a four-part blog series highlighting FDA designations for products…
FDA Designations for Rare Disease Products, Part 1
Comparing Orphan Drug, Rare Pediatric Disease, and Humanitarian Use Device Designations The FDA offers sponsors…
What is 505(b)(2)?
The 505(b)(2) new drug application (NDA) is one of three U.S. Food and Drug Administration...
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The Opportunity for Generics Companies and Value Added Medicines in the US and Europe
To succeed in today’s highly competitive pharmaceutical landscape, differentiation is key. In recent years, many…
A Vitamin Approved as a Drug(!): Forget what you think you know to be true
Dogma says that a compound used for a nutrition, such as a vitamin, cannot be…
Optimizing Your Global Drug Development Program: Strategy for Regional Variations of the 505(b)(2) Pathway
At Premier Consulting, we are often asked for strategic advice on drug development programs seeking…
The New Reality of Generics under GDUFA
From recent news, we know that the FDA has been under increasing pressure to reduce…
DESI Drugs: Potential Targets for Quick Approvals
Drugs that are on the market but are not approved by the FDA are more…
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…
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…
Enforcement Activities: FDA removes unapproved prescription ear drops
For years FDA has threatened to remove unapproved products (so-called DESI products) from the marketplace….
Examining the Amarin VASCEPA Saga
The headlines and newscasts reported Amarin’s success in wining off-label promotion, but behind the scenes,…
Use of Extrusion-Enabled Pharmaceutical Processes in Drug Development via a Streamlined Regulatory Pathway
Extrusion-enabled pharmaceutical processing (E2P2) has long been employed in pharmaceutical development (Drug Development and Industrial…
PREA and 505(b)(2)
Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new active…