USFDA: CDER Establishes New Center for Real-World Evidence Innovation (CCRI)
USFDA Guidance: Standardized Format for Electronic Submission of NDA and BLA Content for Bioresearch Monitoring (BIMO) Inspections
USFDA Draft Guidance: Accelerated Approval – Expedited Program for Serious Conditions
USFDA Final Guidance: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions
USFDA Guidance: Enhancing Communication and Guidance Development Practices
USFDA MD Guidance: Enhancing Safety and Efficiency in Orthopedic Devices and Sterilization Processes
USFDA Guidance: 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review
USFDA Guidance: Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics
USFDA Guidance: Study Data Technical Conformance Guide - Technical Specifications
USFDA Guidance: M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms
US FDA Draft Guidance: Drug Interaction Information in Human Prescription Drug and Biological Product Labeling
USFDA Guidance: Core Patient-Reported Outcomes in Cancer Clinical Trials & Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development
USFDA Guidance : Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers
USFDA Medical Device: Guidance on Dental Products (Dental Impression Materials, Dental Ceramics, Dental Cements and Air Powered Dental Handpieces and Air Motors)
USFDA Guidance: An Acceptable Circular of Information for the Use of Human Blood and Blood Components
USFDA Guidance: Providing Regulatory Submissions in Electronic Format Using eCTD Specifications
USFDA Guidance: Amendments to Abbreviated New Drug Applications (ANDAs) Under GDUFA
USFDA Guidance: Appeal Options for Mammography Facilities
USFDA Guidance: Incorporating Voluntary Patient Preference Information Over the Total Product Life Cycle
USFDA Guidance: Control of Nitrosamine Impurities in Human Drugs