USFDA Statement: New Patient Medication Information - Medication Guide for Patients
USFDA Guidance: Covariates RCT, Non-Clinical Performance Assessment of Tissue & Efficacy Endpoints
USFDA Guidance: Study Data Technical Conformance Guide - Technical Specifications
USFDA Guidance: Pediatric Drug Development - Regulatory and Scientific Considerations
USFDA Guidance: Testing of Glycerin & High Risk Drug Components & CBER Guidances on Blood Products
USFDA Guidance: Assessing User Fees Under the PDUFA of 2022
ICH/USFDA Final Guidance: Q9(R1) Quality Risk Management
USFDA Guidance: Decentralized Clinical Trials for Drugs, Biological Products, and Devices
ICH/ USFDA Guidance: S12 Nonclinical Biodistribution Considerations for Gene Therapy Products
USFDA Guidance: Animal Rule Developing Drugs for Prevention & Treatment "Acute Radiation Syndrome"
USFDA Guidance: Transdermal and Topical Delivery Systems for ANDAs
USFDA Guidance: Format and Content for OTC Monograph Order Requests
USFDA Q&A: A Risk-Based Approach to Monitoring of Clinical Investigations
USFDA Guidance: Clinical Outcome Assessments Into Endpoints for Regulatory Decision
USFDA Guidance: Permanent Discontinuance or Interruption in Manufacturing of Finished Products &API
USFDA Guidance: Identification of Medicinal Products — Implementation and Use
USFDA Med Dev: Marketing Submission Recommendations for Change Control Plan for AI/ML Enabled Device
USFDA MD Guidance: Cybersecurity-Refuse to Accept Policy for Cyber Devices & Related Systems
USFDA Update: In-Person, Face-to-Face ANDA Program Meetings
USFDA Guidance: General Considerations for Animal Studies Intended to Evaluate Medical Devices