CMC Post Approval Manufacturing Changes for Specified BLA - in Annual Reports 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Draft Guidance on Assessing Registries to Support Regulatory Decision -USFDAYesterday, the USFDA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Draft Guidance for Device Software in Premarket Submissions - USFDA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 Q&A Quality (CMC) Related Controlled Correspondence for Generic Drugs
USFDA finalizes Q&As on Biosimilar Development
USFDA’s Study Data Technical Conformance Guide & Technical Specifications Doc Update -USA
USFDA's updated guidance on Development of ANDA During the COVID-19 Pandemic – Q&A -USA
Draft MD Guidance on Performance Criteria for Safety and Performance Based Pathway - USFDA
Draft Guidance on PK-Based Criteria for Alternative Dosing Regimens for Treatment of Cancer - USFDA
FDA Export Certification - Revised Guidance -US FDA
Revised Draft Guidance on Bioequivalence Studies for Generic Drugs – US FDA
FY2022 User Fee Table -USFDA
Request for Comments on pre-Hatch-Waxman ‘PANDA’ applications - FDA
Guidance on Development and Submission of Near Infrared Analytical Procedures– USFDA
Guidance on Metastasis-Free Survival as an Endpoint - Prostate Cancer trials – USFDA
Final Guidance - FAR Submission: Q&A – US FDA