Tag Archive | "CDER"

New Case Studies for Solid Dosage, Parenteral Scaleup to be Discussed at Path-Blazing Conference

by Agnes Shanley

Remember the days when every day seemed to bring news of Critical Path developments from FDA? We haven’t heard all that much about the Critical Path lately, so it was nice to it come up today, in news of a new collaboration on clinical data standards as well as a June conference that will examine the best QbD practices for scaling up robust pharmaceutical processes.

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Woodcock Holds Court: Notes from a Lively CDER Town Hall

A town hall meeting held last week at DIA 2010 in Washington, D.C. featured seven of CDER’s key personnel, but it was clear from the start of the meeting who the star of the show would be. Grande Starbucks cup in hand, CDER director Janet Woodcock kicked off the session by providing an overview of hot topics currently on CDER’s plate, and presided over an ensuing Q&A session in which she spoke with candor, passion, and humor about issues critical to CDER’s work. Woodcock’s colleagues played off her lead and, for those used to droll or technical dialogue from the Agency, this session was a breath of fresh air.

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Exploring Three-Letter Acronyms in Bethesda

By Agnes Shanley

Anyone looking for hopeful signs of change in the ongoing industry/FDA impasse on smart manufacturing–specifically, PAT and QbD–was bound to be disappointed by this week’s FDA “Partnering with Industry” meeting in Bethesda.

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Dangling a Carrot: Should PAT Be Mandated, or Incentivized?

At a May 11-12, 2010 conference on PAT and QbD in Bethesda, Maryland, Keith Webber, Deputy Director of FDA’s CDER, explained why the Agency will not mandate PAT for manufacturers. The “backpack video” is below.

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Video: FDA’s Helen Winkle on Quality by Design and the Need to Prioritize Information

At a panel discussion at Emerson’s Users Exchange in September, Helen Winkle, Director of FDA’s Office of Pharmaceutical Science at the Center for Drug Evaluation and Research, discussed the need for industry, and reviewers, to focus on information that is critical to product quality and safety.

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