USFDA Guidances: Preapproval Inspections & Drug Manufacturing Inspections
USFDA Guidances: Topical Generic Drug Products - ANDAs
USFDA Guidance: Multiple Guidances related to Oncology
USFDA Guidance: ANDA Submissions – Prior Approval Supplements - Under GDUFA
USFDA Guidance: Comparability Protocols for Postapproval Changes to CMC in an NDA, ANDA, or BLA
USFDA MD Guidance: Postmarket Surveillance & Procedures for Handling Post-Approval Studies
USFDA Guidance : GDUFA III User Fees & 4 Generic Drug related Guidances
USFDA Guidance: Four Finalized User Fees and Refunds related Medical Devices Guidelines
USFDA Guide: Review of DMF in Advance of Certain ANDA Submissions & Facility Readiness-Under GDUFA
USFDA Guidance: Size, Shape, & Other Physical Attributes of Generic Tablets and Capsules
USFDA Guidance: Traditional Pre-Market Pathways for COVID Tests
USFDA Guidance: Six Finalized Medical Devices Guidelines
USFDA Guidance: Clinical Investigations of Medical Products Involving Children
USFDA Guidance: Electronic Submission Template for Medical Device 510(k) Submissions
USFDA Guidance: Distribution of Approved Naloxone Products -Immediately-in-Effect
USFDA Guide: Updated eCTD 4.0 - TECHNICAL CONFORMANCE GUIDE,
USFDA: Annual Summary Reporting Requirements -Right to Try Act -Final Rule
USFDA: Office of New Drugs Research Program & Guidance - Software Assurance for Production & Quality
USFDA Guidance: Submitting Documents Using Real-World Data & RW Evidence for Drug & Biologics
USFDA Guidance: Content & Format of Labeling for Non-Prescription Drugs, Quantitative Labeling