Guidance for Industry

Help With BPCA, PREA, Initial Pediatric Study Plans (iPSP), Deferral and Waiver Requests

As pharmaceutical consultants engaged in the compilation and submission of marketing applications, we are frequently called upon by our clients to address all or part of their BPCA and PREA needs. This paper is meant to serve as a review and primer for anyone at the Pre-IND stage or who is confronted with the need…

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FDA Creates New Opportunity in Generic Drug Development

Recent events have occurred within FDA that promise to bring previously unavailable therapeutically equivalent generic drug formulations to the U.S. market.  Patients, prescribers, pharmacists and generic manufacturers all stand to gain from these initiatives: On June 21, new FDA Commissioner Scott Gottlieb announced (in FDA Voice) that “Too many patients are being priced out of…

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FDA Publishes List of Off-Patent/Off-Exclusivity Drugs Without Generic Competition

“Today, the U.S. Food and Drug Administration is taking two new, important steps to increase competition in the market for prescription drugs and facilitate entry of lower-cost alternatives. The agency published a list of off-patent, off-exclusivity branded drugs without approved generics, and also implemented, for the first time, a new policy to expedite the review of generic…

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American Medical Association Seeks Inclusion of Drug Prices in DTC Ads

June 9 – FiercePharma reports “AMA aims at DTC ads again, this time to push inclusion of drug prices…Physicians attending the AMA annual conference in Chicago this weekend will again turn their attention to DTC ads with a new proposal to push drugmakers to list retail pricing, much like automakers do…Resolution 236 was introduced by New England medical societies from Connecticut,…

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DIA Chicago: Two Thumbs Up

PDG extends its sincere thanks to DIA, Freeman, Spargo and fellow participants for making the Chicago DIA 2017 Annual Meeting a great one.  We would also like to congratulate our fitbit winner, a Regulatory Affairs Director at a Central NJ pharmaceutical firm. Click here to visit DIA  or here to contact PDG.

Breaking Down Complex Generics

Breaking Down Complex Generics

What are Complex Generics? Complex generics are those that are inherently difficult to duplicate, reviewed by CDER – OGD (not CBER) using 505(j) Abbreviated New Drug Applications (ANDAs), are generally off-patent and represent markets with higher barriers to entry. According to Robert Lionberger, Ph.D. of OGD, Complex generics may be characterized by the following:[1] Complex…

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