The CDER Reorganization: What It Means for Drugmakers - Webinar Recording/Transcript

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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:

  • Why a reorganization? Why now? How the Office of New Drugs is organized now, how it will change, how drugmakers view the changes
  • Day-to-day impact: Specific changes expected to the Office of New Drugs and how they’ll impact what you do every day
  • Is there an upside here? What the FDA says is the goal of restructuring, and opportunities and challenges that could result
  • NDAs: The specific impact on new drug application reviews
  • Drug product quality and compliance: How the restructuring may affect these critical CDER and FDA functions, and others beside
  • And much more

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:

  • C-Suite
  • Quality executives
  • Regulatory/compliance
  • Manufacturing/operations
  • Design engineers

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.