Draft Guidance on PK-Based Criteria for Alternative Dosing Regimens for Treatment of Cancer - USFDA
Malaysia release GUIDANCE on "FOREIGN GMP INSPECTION"- NPRA
GCC Guidance on Labeling Information, SPC and PIL - Gulf Cooperation Council & SFDA
FDA Export Certification - Revised Guidance -US FDA
Revised Draft Guidance on Bioequivalence Studies for Generic Drugs – US FDA
Updated Prescription Medicines Registration Process – TGA Australia
Request for Comments on pre-Hatch-Waxman ‘PANDA’ applications - FDA
Guidance’s on GMP for Investigational Products & for R&D facilities -WHO
Guidance on Development and Submission of Near Infrared Analytical Procedures– USFDA
Guidance on Metastasis-Free Survival as an Endpoint - Prostate Cancer trials – USFDA
Guidance on Variations, Extensions, Doc Protections, Form & Criteria Annex – Swissmedic -HMV4
Guidance on Developing Drug Shortage Management Plans - France - ANSM
Pre-Authorisation Procedural Advice for Users of the Centralised Procedure - EMA
Guideline on Quality Documentation for Drug-Device Combination Products - EMA
ICH Q13 Draft Guideline reaches Step 2 of the ICH process
FDA’s revised MAPP Procedures for Generic Drug Labeling Change
Guidance on Packaging for Human Medicinal Products, Med.Prod Names & eSubmissions platform - Swiss
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) – EMA
Latest reforms to Post-Market Monitoring of Medical Devices- Australia’s TGA
Draft guidance for Transdermal Adhesion Systems– US FDA