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USFDA draft guidance on : Cover Letter for Controlled Correspondences & ANDA Submissions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
Parallel Imports of Human Medicines– Ireland HPRA
Regulations & Requirements for Conducting Clinical Trials – SFDA
USFDA publishes FY 2022 GDUFA Science & Research Priority Initiatives & FY 2022 collaboration
Guidance on QPPV including Pharmacovigilance System Master Files– MHRA
Draft Guidance on Assessing Registries to Support Regulatory Decision -USFDAYesterday, the USFDA
MHRA’s updated Guidance on URGENT SAFETY MEASURE – UK
Pharmaceutical Reference Standard – Guidance Update - SFDA
Post-Authorisation Procedural Advice for Users of the Centralised Procedure – Updated guideline EMA
Imports & Exports of Therapeutic Goods - Pakistan (DRAP)
Guideline for Registration of Drug-Medical Device & Med.Dev-Drug Combo Products - MALAYSIA -NPRA
Data Standards for Drug & Biological Product Submissions Containing Real-World Data - USFDA
Updated Guideline on Registry-Based Studies (EMA)
Finland adopts New Act on Clinical Trials Legislation (FIMEA)
Saudi Arabia’s (SFDA) Guide on Regulatory Framework for Drug Registration, Variation or Renewals