FDA Guidance Documents Update

Recently Posted Guidance Documents

6/9/15: Duchenne Muscular Dystrophy and Related Dystrophinopathies: Developing Drugs for Treatment Guidance for Industry

6/9/15: CVM GFI #108 How to Register with the CVM Electronic Submission System

6/9/15: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Guidance for Industry

6/10/15: Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry (Small Entity Compliance Guide)

6/11/15: Assessment of Male- Mediated Developmental Risk for Pharmaceuticals Guidance for Industry

6/12/15: CVM GFI #218 - Cell-Based Products for Animal Use

6/12/13: CVM GFI #221 Recommendations for Preparation and Submission of Animal Food Additive Petitions

Guidance Document Search

• Search all FDA official guidance documents and other regulatory guidance