SEC meets to discuss EUA applications from Pfizer, SII and Bharat Biotech
To reconvene on Jan 1, 2021
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Browsing Tag
CDSCO
SEC asks Bharat Serums to revise phase I/II trial protocols for equine antiserum to treat COVID-19
The SEC has recommended grant of permission to conduct the clinical trial provided the company submits the revised clinical trial…
Zydus seeks approval for Phase III clinical trials of ZyCoV-D, submits Phase I/II clinical trial…
ZyCoV-D was found to be safe, well tolerated and immunogenic in the Phase I/II clinical trials, informs company
DoP forms five-member technical committee for Phase II PLI scheme
Dr Eswara Reddy, CDSCO; Dr Amol Kulkarni, NCL, Pune; Prof Arvind Bansal, NIPER Mohali; Satish Khanna, Fullife Healthcare and…
CDSCO to identify and set up two additional facilities for testing COVID-19 vaccines
The CDSCO has identified the challenges associated with COVID-19 vaccines are taking steps to mitigate them, informs Dr Eswara…
Drugs & Cosmetics Act, 1940: Recommendations for a revamp
The existing Drugs and Cosmetics Act of 1940 was formed during the pre-independence era. Since then, amendments have been made to…
Experts seek data on remdesivir and COVID-19 treatment-related products
Ask for details of specific indications for which approval has been granted, any conditions or restrictions attached to the…
Industry positive about CDSCO’s move to digitalise regulatory approvals
Stakeholders share suggestions for a smooth transition
SEC asks CDSCO to submit adverse event report of death during Umifenovir trial
It should include analysis of the ethics committee, investigator and sponsor etc., for review
Bharat Biotech told to provide phase II data of Covaxin before phase III trial
The SEC also observed that the vaccine was well-tolerated in all dose groups and no serious adverse events have been reported so…