Guidance on Revising ANDA Labeling Following Revision of the RLD Labeling
Patients’ Experiences & Engagements Medical Device Guidances - USFDA
USFDA Guidance update on Generic Drug Application Submissions, Labeling, and Review
First Oral Antiviral (PFIZER) for Treatment of COVID-19 -USFDA
Unannounced Inspections in India And China to be Resumed Soon: USFDA
Guidance for Residual Solvents: Q3C(R8) Impurities
CMC Post Approval Manufacturing Changes for Specified BLA - in Annual Reports USFDA
USFDA draft guidance on : Cover Letter for Controlled Correspondences & ANDA Submissions
Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making
Updated Version of Clinical Outcome Assessment Compendium -USFDA
USFDA publishes FY 2022 GDUFA Science & Research Priority Initiatives & FY 2022 collaboration
Draft Guidance on Assessing Registries to Support Regulatory Decision -USFDAYesterday, the USFDA
Knowledge aided Assessment and Structured Application (KASA) Initiative
Draft Guidance for Device Software in Premarket Submissions - USFDA
USFDA’s drafts “Benefit-Risk Assessment for New Drug and Biological Products” Guidance
FDA’s finalized “Interpreting Sameness” Gene Therapy Products Guidance
USFDA’s Electronic Submission Template for Medical Device 510(k) Submissions
USFDA’s Real-World Data: Assessing e-Health Records & Med Claims Data To Support Regulatory Decision
USFDA’s Q&A Quality (CMC) Related Controlled Correspondence for Generic Drugs
USFDA finalizes Q&As on Biosimilar Development