Download our Latest Paper: 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 Best Pharmaceutical for Children Act (BPCA) and Pediatric Research Equity Act (PREA) needs. This paper is meant to serve as a review and primer for anyone at Pre-IND…

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FDA Creates New Opportunity in Generic Drug Development; Public Meeting Held July 18

PDG recently reported that FDA took the unprecedented step of publishing a list of off-patent, and off-exclusivity branded drugs without approved generics. The agency intends to update this list every six months. At the same time, the agency implemented a new policy designed to “expedite the review of generic drug applications where competition is limited.”…

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FDA Publishes List of 1000+ Class II Devices Exempt/Partially Exempt From 510(k) Requirements

Received from CDRH July 10, 2017: “Today’s Federal Register announces a list of 1,003 class II device types that the FDA believes are sufficiently well understood and do not present risks that require premarket notification review to provide a reasonable assurance of safety and effectiveness. In an effort to decrease regulatory burdens on the medical…

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FDA Announces New Draft Guidance on the Use of Electronic Records

The new draft guidance entitled Use of Electronic Records and Electronic Signatures in Clinical Investigations under 21 CFR Part 11 — Questions and Answers, “clarifies, updates and expands upon” a draft guidance issued in 2003 and “provides recommendations to sponsors, clinical investigators, IRBs, CROs, and other interested parties on the use of electronic records and…

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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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