Recently Posted Guidance Documents on Drugs and Food Safety

Drugs

5/11/2018 Pediatric HIV Infection: Drug Development for Treatment

5/10/2018 Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act

5/9/2018 S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies: Focus on Microsampling

5/9/2018 Uncomplicated Urinary Tract Infections: Developing Drugs for Treatment Guidance for Industry

5/8/2018  Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act Guidance for Industry

Food Safety

5/9/2018  Guidance for Industry: The FDA Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules: What You Need to Know About the FDA Regulation: Small Entity Compliance Guide