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US FDA Draft Guidance: Drug Interaction Information in Human Prescription Drug and Biological Product Labeling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
USFDA Guidance: Bioresearch Monitoring Technical Conformance Guide
USFDA Guidance: Electronic Submissions for De Novo Requests and Section 513(g) Requests for Information
USFDA Guidance: Predetermined Change Control Plans for Medical Devices
USFDA Guidance: Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA
USFDA Guidance: User Fee Programs: GDUFA, BSUFA, OMOR, and MDUFA
USFDA Guidance: Utilizing Real-World Data in Regulatory Decision-Making for Drug and Biological Products
USFDA Guidance: Providing Over-the-Counter Monograph Submissions in Electronic Format