Here’s a list of the notable guidances released by FDA in September 2011, compiled by Cato Research Regulatory Scientist Cathy Anderson.
- Reproductive and Developmental Toxicities – Integrating Study Results to Assess Concerns
- User Fee Waivers, Reductions, and Refunds for Drug and Biological Products
- De Novo Classification Process (Evaluation of Automatic Class III Designation) (Draft)
- Self-Selection Studies for Nonprescription Drug Products (Draft)
- Marketed Unapproved Drugs – Compliance Policy Guide
- Time and Extent Applications for Nonprescription Drug Products
- Media Fills for Validation of Aseptic Preparations for PET (Draft)
- August 2011 FDA Guidances (ask-cato.com)
- New FDA Guidances Released in July 2011 (ask-cato.com)
- Free Webinar: Understanding the New FDA Validation Criteria (theectdsummit.com)








