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The CDER Reorganization: What It Means for Drugmakers — Preparing Now for NDA Impact
Drug, biologics and combination product makers with new drug approvals (NDA) in the pipeline are bracing for fallout from the planned reorganization of CDER, the Center for Drug Evaluation and Research.
Will the new therapeutic focus help or hurt you? And what action should you take now? FDAnews has answers.
Former FDA investigator and ORA director Ricki A. Chase — now a consultant advising big-pharma clients on successful ways to deal with the agency — digs into details of the revamp and suggests how they could affect you. You’ll discover:
New-drug approval — or denial — can make or break you and your organization. The CDER reorganization is expected to hit NDAs first and worse.
Drug, biologic and combination product makers with current or pending NDAs. Target attendees include but aren’t limited to:
Ricki A. Chase, a former FDA investigator, specialist, manager and director in the Office of Regulatory Affairs (ORA), is a Director in the Compliance Practice of Lachman Consultant Services Inc. advising Big Pharma clients on successful FDA interactions. Her FDA experience combines with her private-sector perspective for unique insights into agency operations and considerations.
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