FDA Guidance Document Update

Recently Posted Guidance Documents Animal and Veterinary 12/16/16: VICH GL52 - Bioequivalence: Blood Level Bioequivalence Study Biologics 12/13/16: Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans; Guidance for Industry Drugs 12/2/16: Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products — Content and Format 12/8/16: Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification Guidance for Industry 12/14/16: Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers Medical Devices 12/12/16: Immediately in Effect Guidance Document: Conditions for Sale for Air-Conduction Hearing Aids - Guidance for Industry and Food and Drug Administration Staff 12/14/16: Public Notification of Emerging Postmarket Medical Device Signals (Emerging Signals) - Guidance for Industry and Food and Drug Administration Staff Guidance Document Search: Search all FDA official guidance documents and other regulatory guidance