Guide to Reporting and Initial Investigation of Quality Defects-Ireland HPRA
MHRA's New & updated Innovative Licensing and Access Pathway - UK
Draft MD Guidance on Performance Criteria for Safety and Performance Based Pathway - USFDA
Draft Guidance on PK-Based Criteria for Alternative Dosing Regimens for Treatment of Cancer - USFDA
MDCG Guidance for NBs, importers, & distributors: QMS certification for relabelling & repackaging
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Revised Draft Guidance on Bioequivalence Studies for Generic Drugs – US FDA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
Regulation & Re-classification of Software based Medical Devices - TGA Australia
Guidance on Issuing of an Authorization for Med Device based on ASEAN Requirements - PhilippinesFDA
FY2022 User Fee Table -USFDA
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
MDCG Guidance on UDI Integration -European Comission
Clinical Trials Information System (CTIS) to go-live in 6 Months – EMA