China Joins ICH in Pursuit of Global Harmonization of Drug Development Standards

Theresa M. Mullin, Ph.D. of FDA reports “I am pleased to have been in China recently, when the China Food and Drug Administration (CFDA) submitted its membership application to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (also known as the International Council for Harmonisation or ICH).” Click here for the…

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FDA Product-Specific Guidances Page Updated; Nearly 50 New Guidances Added

On August 15, 2017, FDA updated its page entitled Product-Specific Guidances for Generic Drug Development. In October 2016 we reported that “FDA Adds 67 New/Revised Product Specific Bioequivalence Guidances.” This latest addition is noteworthy because it includes finalized bioequivalence guidances, which the Agency has not done since September 2015. Click here to see the additions…

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FDA OTC Monograph Changes Coming: User Fees, Pre-submission Meetings and Electronic Submissions

FDA User Fees for Reliance on the FDA OTC Monographs? Although not included in FDARA, there is a reasonable possibility the proposed Over-the-Counter Monograph User Fee Program (OMUFA) will still become law. Assuming passage, Over-the-Counter (OTC) User Fees and electronic submissions will be required and sponsors will have the opportunity to engage in pre-submission meetings…

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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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