USFDA Guidance: Content and Format of Composition Statements in NDAs and ANDAs and Corresponding Statement of Ingredients in Labeling
USFDA Guidance: Cancer Clinical Trial Eligibility Criterias
USFDA Guidance: Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Q&A
USFDA: Guidance one eSubmission of Expedited Safety Reports From IND-Exempt BA/BE Studies and Data Integrity for In Vivo BA & BE studies
USFDA Guidance: Regional Implementation Guide for E2B (R3) e-Transmission of ICSR and Providing Regulatory Submissions in Electronic Format: IND Safety Reports
USFDA Guidance: Handling and Retention of Bioavailability (BA) & Bioequivalence (BE) Testing Samples
USFDA Guidance: Controlled Correspondence Related to Generic Drug Development
USFDA Guidance: Annual Reportable Labeling Changes for NDA and ANDA for Nonprescription Drug Products
USFDA Med.Dev: Draft Guidance Select Updates for the Premarket Cybersecurity -Section 524B of the FD&C Act
USFDA Guidance: Clinical Pharmacology Considerations for Antibody-Drug Conjugates
USFDA Guidance: Reporting Amount of Listed Drugs and Biological Product and Key Information and Facilitating Understanding in Informed Consent Guidance
USFDA Guidance: Q&A-Charging for Investigational Drugs Under an IND - What You Need to Know
USFDA Guidance: Use of Data Monitoring Committees in Clinical Trials
USFDA CMC Guidance: Advanced Manufacturing Technologies Designation Program
USFDA Guidance: "Understanding FDA's QMSR Final Rule: What You Need to Know for the Transition Period"
USFDA Guidance: Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products
USFDA Guidance: Human Gene Therapy Products Incorporating Human Genome Editing & Development of Chimeric Antigen Receptor (CAR) T Cell Products
USFDA Guidance: Conducting Remote Regulatory Assessments Questions and Answers
USFDA Guidance: Navigating ANDA Submissions Latest Guidance on ANDA Amendments, Requests, and Labeling Revisions
USFDA's ISTAND Pilot Program: Accepts First Submission of AI-Based Digital Tech for Neuroscience