FDA's upcoming process validation guidance will reflect a combination of traditional and QbD-like process design requirements, Joseph Famulare, deputy director of CDER's Office of Compliance, said at an Oct. 15 meeting sponsored by Pharmaconference and the University of Rhode Island College of Pharmacy in Bethesda, Md. He noted that the upcoming guidance has involved all parts of the centers for drugs, biologics and veterinary medicine and the Office of Regulatory Affairs. He further noted that "if you have a lot of knowledge management, this can be factored into the protocol. The protocol will be used to justify your batch number." Echoing the remarks of other FDA officials on the upcoming guidance, Doug Ellsworth, FDA's New Jersey District Director, said that "the Barr decision produced the three batches. Now everyone denies saying it. Three batches are gone. There is now a lifecycle approach to validation.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
Sarepta's rAAVrh74 vector, used in the marketed Duchenne muscular dystrophy gene therapy Elevidys and across the company's limb girdle muscular dystrophy pipeline, earned a platform designation as the lead LGMD candidate prepares for BLA filing.
Pink Sheet reporter and editors discuss the potential impact of the Most-Favored Nation drug pricing proposal on Europe, the United States, as well as the pharmaceutical industry.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
