Recently Posted Guidance Documents U.S. Food and Drug Administration sent this bulletin at 05/22/2022 06:56 PM EDT If your email program has trouble displaying this email, view as a webpage. Recently Posted Guidance Documents 5/19/2022 - Draft Guidance for Industry: Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-market Notification 5/19/2022 - Risk Management Plans to Mitigate the Potential for Drug Shortages 5/18/2022 - Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors 5/17/2022 - Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 5/16/2022 - Guidance for Industry: Infant Formula Enforcement Discretion Policy 5/16/2022 - Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production - Level 2 revision: Guidance for Industry 5/13/2022 - Guidance for Industry: Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting 5/10/2022 - CVM GFI #3 General Principles for Evaluating the Human Food Safety of New Animal Drugs Used In Food-Producing Animals 5/10/2022 - CVM GFI #272 Practices to Prevent Unsafe Contamination of Animal Feed from Drug Carryover 5/9/2022 - Benefit-Risk Considerations for Product Quality Assessments 5/6/2022 - Feasibility and Early Feasibility Clinical Studies for Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients with Type 2 Diabetes Mellitus: Guidance for Industry and Food and Drug Administration Staff 5/6/2022 - Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program: Draft Guidance for Industry and Food and Drug Administration Staff 5/4/2022 - Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies 5/4/2022 - Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised): Guidance for Industry and Food and Drug Administration Staf 5/2/2022 - Use of Circulating Tumor Deoxyribonucleic Acid for Early-Stage Solid Tumor Drug Development; Draft Guidance for Industry; Availability Guidance Document Search Search all FDA official guidance documents and other regulatory guidance
