Search
Sharan Murugan
- Mar 5
- 2 min
India CDSCO: Draft Guidance on Post Approval Changes (PAC’s) for Biologicals for consulataion
India's Central Drugs Standard Control Organization (CDSCO) has published draft guidance "Post Approval Changes in Biological Products:...
57 views0 comments
Sharan Murugan
- Dec 18, 2021
- 1 min
CMC Post Approval Manufacturing Changes for Specified BLA - in Annual Reports USFDA
This guidance provides recommendations to holders of biologics license applications (BLAs) for specified biological products regarding...
20 views0 comments