Web9 Sep 2024 · The agency has several bodies with different responsibility including: Subject Expert Committee (SEC) for clinical review which comprises external physicians and regulators; the Review Committee for Genetic Manipulation (RCGM) for non-clinical data; and the Department of Biotechnology (DBT) for developing and defining regulatory … Web12 Apr 2024 · As per standard procedure, all clinical and non-clinical data has to be reviewed in consultation with the Subject Expert Committee. If deficiencies are found during the review, CDSCO should notify the applicant within the prescribed timelines and the applicant has to furnish the required information as soon as possible.
SUBJECT EXPERT COMMITTEE OF CDSCO - The Economic Times
Web25 Jan 2024 · Drugs & Vaccines safety monitoring, Coordination & Supervision of Adverse Drug Reaction data collection by HCPs, review of ICSR forms, spontaneous reporting to WHO & IPC (CDSCO), providing... Web31 Oct 2024 · New Delhi: Citing that drug maker, Intas Pharma should report in case of any Serious Adverse Events (SAEs) related to the Phase III clinical trial of Tofacitinib Ointmen t 2%, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has approved the continuation of the clinical trial of the drug … denhigh gmail.com
Committee_Meetings - Central Drugs Standard Control Organisation
Web2 days ago · Background. To assess safety and tolerability of a diphtheria and tetanus toxoid, acellular pertussis, inactivated poliovirus and Haemophilus influenza type B conjugate adsorbed vaccine (DTaP-IPV+Hib), manufactured by Serum Institute of India Pvt. Ltd. (SIIPL)’s, the current first-in-human Phase 1 study was conducted in healthy adults. Web20 Jan 2024 · Indian drug regulator CDSCO’s subject expert committee has recommended granting permission for conducting Phase I clinical trial of Bharat Biotech’s intranasal Covid-19 vaccine (BBV154). The company plans to begin Phase I human clinical trials during February-March this year. Credit: hakan german from Pixabay. Web10 Apr 2024 · New Delhi: The drug major Glenmark has got the go ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization … ff burhave