USFDA's updated guidance on Development of ANDA During the COVID-19 Pandemic – Q&A -USA
UK’s Updated Guidance on Managing Clinical Trials due to COVID-19 & Access to eHealth Records -MHRA
USFDA's Novel Excipient Review Pilot Program
Malaysia-NPRA Releases Guidelines on Good PharmacoVigilance (GPv) Practices
Swissmedic Updates Forms for New Authorization, Variations & Extensions-Switzerland
Updated Guidance for e-Submissions for CEP applications
Guide to Reporting and Initial Investigation of Quality Defects-Ireland HPRA
MHRA's New & updated Innovative Licensing and Access Pathway - UK
Draft Guidance on PK-Based Criteria for Alternative Dosing Regimens for Treatment of Cancer - USFDA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Revised Draft Guidance on Bioequivalence Studies for Generic Drugs – US FDA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