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  • Regulatory NewsRegulatory News

    India Looks to Further Ease Process of Running Clinical Trials

    India’s Central Drugs Standard Control Organization (CDSCO) on Tuesday looked to relax two clinical trial requirements that could make it easier to run trials there. In two joint circulars – from CDSCO, the Directorate General of Health Services, the Ministry of Health and Family Welfare and signed by G.N. Singh, Drugs Controller General –  India will no longer stop trial investigators from conducting more than three trials at a time, and India will revise its requireme...
  • Regulatory NewsRegulatory News

    India’s CDSCO Releases New Clinical Trial Guidelines

    India’s Central Drugs Standard Control Organisation (CDSCO) has released a slew of orders making a wide range of changes to the agency’s policies governing clinical trials.  New policies stated in the documents include: Sponsors, investigators, the regulator and Ethics Committees are responsible for ensuring that the design of placebo-controlled trials is appropriate, efficient and ethical; Investigators are limited to working on a maximum of three trials simultan...
  • FDA Raids Compounding Facility Linked to Meningitis Outbreak

    Criminal investigators from the US Food and Drug Administration (FDA) have raided the New England Compounding Center (NECC), the facility linked with supplying tainted injectable steroid products that have infected hundreds with a dangerous form of fungal meningitis that has already claimed the lives of 19. The move, made 17 October, is perhaps FDA's most forceful yet against the pharmacy. NECC has thus far been cooperating with the agency on an extensive but voluntary b...
  • FDA Releases Final Guidance on Overseeing Clinical Trials

    The US Food and Drug Administration (FDA) released new guidance 27 February on clinical trials oversight occurring after clinical investigation approval (CIA). Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Continuing Review after Clinical Investigation Approval finalizes draft guidance by the same name released by FDA in January 2010. The guidance aims to provide specific recommendations for Institutional Review Boards, sponsors and clinical investig...