FDA's Draft Guidance on Cybersecurity in MD: Quality System Consideration & Content of Premarket Sub
FDA's: OTC Monograph Drug User Fees for Fiscal Year 2022
USFDA Guidance on Verification Systems & Voluntary Recalls
USFDA: 3 updated Guidance on PLAIR, VQIP & Recalls
USFDA Guidance: Methods to Identify What Is Important to Patients
USFDA - Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs
USFDA Guidance on Premarket Review of Combination Products
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 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Draft Guidance on Assessing Registries to Support Regulatory Decision -USFDAYesterday, the USFDA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Draft Guidance for Device Software in Premarket Submissions - USFDA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