USFDA’s Electronic Submission Template for Medical Device 510(k) Submissions
India CDSCO -Guide for Manufacturers/Importers for Registration of Non-Notified Medical Devices
USFDA’s Real-World Data: Assessing e-Health Records & Med Claims Data To Support Regulatory Decision
USFDA’s Q&A Quality (CMC) Related Controlled Correspondence for Generic Drugs
Swissmedic- Updated Guidance on Authorisation of Human Med.Product with New Active Substance
USFDA finalizes Q&As on Biosimilar Development
Denmark- Updated Guidance on Implementation Of Decentralised Elements In Clinical Trials
USFDA’s Study Data Technical Conformance Guide & Technical Specifications Doc Update -USA
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