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Há 5 dias · In a recent discussion, Peter Marks, the director of the FDA's Center for Biologics Evaluation and Research, and Janet Woodcock, former FDA deputy commissioner, highlighted the critical need for regulatory flexibility in developing rare disease therapies.
Há 4 dias · Former Acting FDA Commissioner Janet Woodcock proposed the creation of a new approval pathway for therapies when it is impossible to conduct trials required to meet standard requirements. Woodcock sparked much of the controversy over regulatory flexibility in 2016 by overruling FDA staff and approving Exondys 51 eteplirsen from Sarepta Therapeutics Inc. (NASDAQ:SRPT) for Duchenne muscular ...
Há 2 dias · Factors such as increased competition and resulting cost pressures in the biopharmaceutical market, new modalities for personalized medicine, and reported threats of drug shortages provide incentives for organizations to develop, in the words of the Janet Woodcock, Director of FDA CDER, a “maximally efficient, agile, flexible ...
Há 1 dia · And natural history data is often, pointed out, to us. Janet Woodcock, when she was at the FDA, would say this to us when patient advocacy groups and rare disease biotechs were gathered in the same room with her. She say, you need to characterize your diseases better, you patient advocacy groups. You need natural history data.
Há 4 dias · The focus on technology as a driver of performance improvement in clinical trials is intense, but despite years of valiant efforts, study execution remains far from optimal.
Há 3 dias · Speakers at the Scientific Workshop will include Dr. Peter Marks, Director of FDA’s Center for Biologics Evaluation and Research, Dr. Janet Woodcock, former Principal Deputy Commissioner of the FDA, Dr. Janet Maynard, Director of the FDA’s Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicines, and Dr. Joni ...
Há 2 dias · Exciting developments in the biotech world! Following the success of GLP-1 weight loss drugs like Wegovy and Zepbound, numerous companies are now exploring…
