USFDA's Notice: CMC Development & Readiness Pilot Program
USFDA Guidance: Developing & Responding to Deficiencies - Least Burdensome Provisions
USFDA Guidance: Multiple Endpoints in Clinical Trials & Gene Therapy for Neurodegenerative Diseases
USFDA MD Guidance: Breakthrough Devices Program - Reducing Disparities in Health & Health Care
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,