USFDA Guidance: Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics
USFDA Guidance: BIMO Inspections Processes, Practices & Standardized Format for Electronic Submission
USFDA Guidance: Platform Technology Designation Program for Drug Development
USFDA Med Dev: Guidance on Remanufacturing of Medical Devices
USFDA Guidance: REMS Logic Model: A Framework to Link Program Design With Assessment
USFDA MD Guidance: Enforcement Policies for Tests During a Section 564 Declared Emergency & for Certain In Vitro Diagnostic Devices
USFDA Guidance: Considerations for the Use of Human-and Animal-Derived Materials & Recognition and Use of a Standard for Uniform Blood & Blood Component Container Labels
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USFDA Med.Dev: Draft Guidance Select Updates for the Premarket Cybersecurity -Section 524B of the FD&C Act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