Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act-2025/12/22

Processes and Practices Applicable to Bioresearch Monitoring Inspections-2025/12/19

Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices-2025/12/18

Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry-2025/12/17

ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs-2025/12/16

Study Data Technical Conformance Guide - Technical Specifications Document-2025/12/16

Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies-2025/12/15

Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices-2025/12/15

Study of Sex Differences in the Clinical Evaluation of Medical Products-2025/12/15

Enhancing Participation in Clinical Trials — Eligibility Criteria, Enrollment Practices, and Trial Designs-2025/12/15