USA Today reported on August 15 that “Drugmakers ‘game the system and game the rules’ through a patient safety program that allows them to keep generic drug companies from getting enough doses of their branded drug, said Gottlieb. Generic drugmakers need up to 5,000 doses to do the studies needed to prove their products are truly equivalent, he…
DetailsTheresa 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…
DetailsOn 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 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…
DetailsThe number of orphan designation requests has more than doubled in the last five years. Last fiscal year saw 568 new requests, and as of July 2017 there are 200 pending review. The announcement of the new Orphan Drug Modernization Plan comes one week after the new FDA Commissioner committed to eliminating the backlog within 90 days.…
DetailsAs 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…
DetailsPDG 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.”…
DetailsReceived 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…
DetailsFiercePharma reported on July 7, 2017 that “After backing candidate Donald Trump last year, antivaccine activists may feel betrayed in his administration’s latest move to name vaccine advocate Brenda Fitzgerald to run the CDC. At the same time, the medical community will likely breathe a sigh of relief on the nomination. Health and Human Services…
DetailsFDAnews Drug Daily Bulletin reports that “FDA is proposing to shorten ANDA review timelines for certain generics sponsors that submit advance information to the agency. PFCs are one of several enhancements specified by the GDUFA II commitment letter to streamline the review process for priority ANDAs. In the commitment letter, the FDA pledged to review…
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