Search
Sharan Murugan
- Sep 29, 2021
- 1 min
USFDA’s Electronic Submission Template for Medical Device 510(k) Submissions
On 28-September, 2021 USFDA released draft guidance to assist sponsors in using an electronic template for submitting a premarket...
24 views0 comments
Sharan Murugan
- Sep 29, 2021
- 1 min
India CDSCO -Guide for Manufacturers/Importers for Registration of Non-Notified Medical Devices
India’s Central Drugs Standard Control Organization (CDSCO) has published the steps that need to be followed by the manufacturers and...
25 views0 comments
Sharan Murugan
- Sep 29, 2021
- 2 min
USFDA’s Real-World Data: Assessing e-Health Records & Med Claims Data To Support Regulatory Decision
On 28-September, 2021 USFDA released the guidance “Real-World Data: Assessing Electronic Health Records and Medical Claims Data To...
26 views0 comments
Sharan Murugan
- Sep 23, 2021
- 1 min
USFDA’s Q&A Quality (CMC) Related Controlled Correspondence for Generic Drugs
On 20.09.2021, USFDA released an updated Questions and Answers on Quality-Related Controlled Correspondence Guidance for Industry. This...
220 views0 comments
Sharan Murugan
- Sep 23, 2021
- 1 min
Swissmedic- Updated Guidance on Authorisation of Human Med.Product with New Active Substance
On 17.09.2021, swiss medic released an updated Guidance on Authorisation of Human Medicinal Product with New Active Substance HMV4. The...
68 views0 comments