Subject expert committees: Past, present, and future

• Published in: Perspectives in clinical research Vol. 10; no. 1; pp. 1 - 3
• Main Authors: Bhave, Amita, Menon, Suresh
• Format: Journal Article
• Language: English
• Published: India Wolters Kluwer India Pvt. Ltd 01.01.2019; Medknow Publications and Media Pvt. Ltd; Medknow Publications & Media Pvt. Ltd; Medknow Publications & Media Pvt Ltd; Wolters Kluwer Medknow Publications
• Subjects: Analysis; Clinical decision making; Committees; Decision making; Drugs; Experts; FDA approval; Handbooks; Meetings; Oncology; Patient safety; Public health; United States > US; India
• ISSN: 2229-3485; 2229-5488
• DOI: 10.4103/picr.PICR_196_18

In March 2011, the CDSCO constituted 12 New Drug Advisory Committees (NDACs),[1] consisting of experts from government medical colleges and eminent institutions within India for review of regulatory applications including new drugs, fixed-dose combinations, additional indications, and clinical trials (CTs). Members attending the SEC meeting should review the CT proposal, forwarded well in advance and submit their comments in 6 weeksMembers must have knowledge of current CT regulations and understanding of GCPThe overall approach of SEC panel should be scientific, rational, focused, advisory, and politeRecommendations should be governed by valid scientific basis and judgmentRecommendations should be explicit and worded in an easy-to-understand languageIf the proposal does not qualify for positive opinion, clear reasons for proposed query/rejection must be provided to CDSCO. ODAC review meeting is convened only at the request of US FDA if the matter is of significant public interest and obtaining advice is beneficial or matter is controversial, for example, FDA reviewers have differences of opinion during the review, or risk-benefit ratio is not straightforward or significant safety concerns or questions about the use of product in certain subpopulation. [...]it is always beneficial to have subject matter experts' advisory to regulators to protect patient safety and well-being.