Regulatory Blog

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