Expediting the FDA Generic Drug Approval Process

PDF Edition - Expediting the FDA Generic Drug Approval Process

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The FDA continues to struggle to catch up on ANDA approvals. Average time to approve: Three years. Three long years.

While it’s not well known, there are ways you can speed the approval process. Inside the pages of Expediting the FDA Generic Drug Approval Process you’ll discover:

  • The three strategies for faster ANDA approvals:

They are 1) seeking an expedited review, 2) filing the ANDA in eCTD format and 3) avoiding refuse-to-receive decisions. Of the three, avoiding RTR decisions is the most important.

You’ll discover the three biggest areas of application deficiencies that trigger RTR decisions — bioequivalence; chemistry, manufacturing and controls (CMC) quality; and organization and formatting — and learn which problems trigger FDA alarm-bells. Plus you’ll see how to avoid other areas that can lead to RTR turndowns, including clinical, sterility assurance, drug substance quality and other deficiencies.

  • How to thread your way through the FDA maze:

You’ll want to file your ANDA as an electronic common technical document (eCTD) because this is the only way for Generic Drug User FeeAct (GDUFA) review performance goals to apply. Significant new review performance goals took effect Oct. 1 with more to come over the next two years. Expediting the FDA Generic Drug Approval Process deconstructs the ANDA amendment process to show how review and approval times may be affected by GDUFA goals tied to different classes of amendments, and how incomplete or poor-quality applications can cause FDA to back off review goal commitments.

  • Plus much more

The management report provides examples of amendments that aren’t subject to GDUFA performance goals, and shows how amendments submitted before or after a complete response letter may affect your ANDAs. You’ll discover:

  • How to avoid easily correctable deficiencies
  • Factors that may lead to a change in an amendment’s classification
  • Little-known impacts of GDUFA, such as generic API and finished dosage form facility fees, drug master file (DMF) completeness assessments, and FDA hiring, procedural and inspection goals

Rounding out the picture, Expediting the FDA Generic Drug Approval Process includes the FDA’s ANDA filing checklist, plus a comprehensive list of FDA guidances and resources on ANDAs.

Why risk any delay whatsoever, when it takes only an hour or two of reading to master the secrets of speedy generic approval? Don’t delay. Order Expediting the FDA Generic Drug Approval Process today.

Order Your Copy Today!

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Table of Contents

  • Strategies for Faster ANDA Approvals
  • Selected RTR Issues and Areas of Concern
  • Amendments and Easily Correctable Deficiencies Under GDUFA

View the entire TOC

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