CDSCO issues clarification on the requirement of process validation report for permission to conduct Clinical trial/BA-BE studies Medical Dialogues Bureau21 March 2020 12:00 PM ISTNew Delhi: Through a recent notice Central Drugs Standard Control Organization (CDSC0), Directorate General of Health Services has clarified the...
BA/BE study applications have to be processed in 15 days: CDSCO Medical Dialogues Bureau25 Feb 2020 12:50 PM ISTNew Delhi: In order to streamline the applications process by various pharma companies, the CDSCO in its notice has recently mandated that BA/BE...