Recently Posted Guidance Documents on Biologics, Drugs, and Food Safety Modernization Act (FSMA)

Drugs

• 10/25/2018  M9 Biopharmaceutics Classification System-Based Biowaivers
• 10/24/2018  Testicular Toxicity: Evaluation During Drug Development Guidance for Industry
• 10/24/2018  Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs Guidance for Industry

Food Safety Modernization Act (FSMA)

• 10/22/2018  Draft Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption

Biologics

• 10/29/2018  Considerations for the Development of Dried Plasma Products Intended for Transfusion; Draft Guidance for Industry