FDA Guidance Documents Update

Recently posted guidance documents:

6/21/16: Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices - Guidance for Industry and Food and Drug Administration Staff

6/22/16: FDA Regional Implementation Specifications for ICH E2B(R3) Reporting to the FDA Adverse Event Reporting System (FAERS)

6/28/16: Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in FDA Advisory Committees

6/29/16: Gifts to FDA: Evaluation and Acceptance

6/30/16: Vulvovaginal Candidiasis: Developing Drugs for Treatment

6/30/16: Elemental Impurities in Drug Products

6/30/16: Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Guidance for Industry

6/30/16: Recurrent Herpes Labialis: Developing Drugs for Treatment and Prevention

Guidance Document Search

• Search all FDA official guidance documents and other regulatory guidance