USFDA Guidance: Manufacturing Changes & Comparability for CGT Products, Good Cause for Noncompliance
USFDA Guidance: Considerations for Optimizing & Standardizing Diet in Clinical Trials (IEM)
USFDA Guidance: Risk & Efficacy Information in Direct-to Consumer Prescription Drug Promo Labeling
USFDA Guidance: Psychedelic Drugs-Considerations for Clinical Investigations
USFDA Guidance: Formal Dispute Resolution and Administrative Hearings for OTC Monograph Drugs
USFDA Guidance: Pilot Program Oncology Drug Products & In Vitro Diagnostic Tests
USFDA Guidance: Content of Premarket Submissions for Device Software Functions
USFDA Guidance: Assessing User Fees Under the GDUFA of 2022
USFDA Guidance: Clinical Drug Interaction Studies With Combined Oral Contraceptives
USFDA/ICH - E6(R3) GCP Guideline: Modernizing the Design & Conduct of Clinical Trials
USFDA Guidance: Cover Letter Attachments for Controlled Correspondences & ANDA Submissions
USFDA Guidance: Drug-Drug Interaction Assessment & Nonclinical Evaluation of Immunotoxicity
USFDA Guidance: Medical Device Submissions "The Q-Submission Program"
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