ICH-Draft Guideline on Pediatric Extrapolation & FInal Guidance on Considerations for Clinical Study
Voluntary GVP Inspection on Pharma Product Registration Holders- Malaysia’s NPRA
ICH's updated Draft Guidelines on Analytical Method Development
Guide to Wholesaling & Brokering of Medicinal Products - Ireland
USFDA's recent Guidance on Biologics: Ophthalmic Products & Development of (CAR) T Cell Products
USFDA Guidance on Verification Systems & Voluntary Recalls
USFDA: 3 updated Guidance on PLAIR, VQIP & Recalls
MHRA adds Health Technology Assessments (HTA) Tool Details to ILAP Guide
Guidance for Clinical Trials Conducted under the Clinical Trials Regulation (CTR) in Ireland
Revision of PIC/S GMP Guide
Ireland's guidance on New Application & Variations, Registartion Requirements,
USFDA Guidance update on Generic Drug Application Submissions, Labeling, and Review
EMA Guidance for Applicants seeking Scientific Advice and Protocol Assistance
UK Guidance on Clinical Trials: How to Apply for Authorization
Unannounced Inspections in India And China to be Resumed Soon: USFDA
CMC Post Approval Manufacturing Changes for Specified BLA - in Annual Reports USFDA
Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making
Draft Guidance on Assessing Registries to Support Regulatory Decision -USFDAYesterday, the USFDA
Data Standards for Drug & Biological Product Submissions Containing Real-World Data - USFDA
ICH guideline Recommendation on Daily (PDE) Limits for Seven Mutagenic Impurities