FDAnews New Management Report: Expediting the FDA Generic Drug Approval Process

Share Article

The FDA continues to struggle to catch up on ANDA approvals with an average approval time of three years. Discover ways to speed up the approval process in the new management report from FDAnews, Expediting the FDA Generic Drug Approval Process.

Expediting the FDA Generic Drug Approval Process
**FDAnews Management Report**
http://www.fdanews.com/ExpeditingGenericDrug

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 to speed up the approval process. Inside the pages of Expediting the FDA Generic Drug Approval Process readers will 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.

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, 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 the way through the FDA maze:

Drugmakers will want to file the ANDA as an electronic common technical document (eCTD) because this is the only way for Generic Drug User Fee Act (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 the ANDAs. Readers will 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?

Who Will Benefit:

  •     Drug company executives
  •     Contract manufacturer executives
  •     API manufacturer executives
  •     Submissions and applications specialists
  •     Strategic planning and life cycle management specialists
  •     General/corporate counsel
  •     Regulatory affairs professionals
  •     Consultants/service providers

Publication Details:
Expediting the FDA Generic Drug Approval Process
**FDAnews Management Report**
http://www.fdanews.com/ExpeditingGenericDrug

Format: Print or PDF
Price: $397

Easy Ways to Order:
Online:     http://www.fdanews.com/ExpeditingGenericDrug
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

Share article on socal media or email:

View article via:

Pdf Print

Contact Author

Michelle Butler
FDANEWS
+1 (703) 538-7665
Email >
FDAnews
Like >
Visit website