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
US FDA CDER Guidance Agenda -Calendar Year 2022
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USFDA draft guidance on : Cover Letter for Controlled Correspondences & ANDA Submissions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Draft Guidance on Assessing Registries to Support Regulatory Decision -USFDAYesterday, the USFDA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