Health Canada: Udated Register of Innovative Drugs
USFDA Guidance: Submitting Documents Using Real-World Data & RW Evidence for Drug & Biologics
USFDA Guidance: Content & Format of Labeling for Non-Prescription Drugs, Quantitative Labeling
USFDA Guidance: Clinical Pharmacology Considerations for Pediatric Studies of Drugs & Biologics
IRIS Updated Guide: How to Create & Submit Scientific Applications & Accelerating Clin. Trials Plan
Singapore HSA: Safety Alert for Finasteride and Potential Risk of Suicidal iIdeation
EMA Guidance: For Applicants/MAHs involved in GMP and GCP Inspections
Health Canada Recommendations: ICH Q3D(R2) Guideline for Elemental Impurities
SFDA Guide to Good Manufacturing Practice for Medicinal Products
ICH Guidances: Q2(R2) Validation of Analytical Procedures, Q14, M12, E11A, E14 & S7B Updation
SFDA: Guidelines for Stability Testing of API and Finished Pharmaceutical Products
EMA: Updated EudraVigilance Registration Manual
Gilead: First Regulatory Approval of HIV Sunlenca® (Lenacapavir) the Only Twice-Yearly HIV Treatment
USFDA Guidance: Charging for Investigational Drugs Under an IND: Questions and Answers
UK MHRA's: Apply for a Parallel Import Licence (Guidance Update)
Europe's EDQM: Nitrosamines – Deadline Extension for all CEP Holders - Now 1 October 2023
UK MHRA Guidance on: Manage your authorisation & Report Safety Issues
Colombia's Invima and USP: Memorandum to Strenghthen the Quality of Medicine
USFDA's New WebPage: For Complex Generics
Health Canada: Guidance Document Management of Drug Submissions and Applications & Post-DIN Changes