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  • Regulatory NewsRegulatory News

    After Intense Scrutiny, FDA Set to Take Another Look at OTC Antiseptics

    The US Food and Drug Administration (FDA) will soon hold a meeting regarding the safety and efficacy of non-prescription antiseptic products, just months after raising concerns about the products to manufacturers. Background OTC topical antiseptics are generally used to prepare a site prior to injection to reduce the chance of site infection. While some of the products are currently distributed in single-use form, many are packaged in multiple-use packages like tubes th...
  • Report: Indian Drug Regulator's Office Has 'Washed Its Hands From Drug Approvals'

    The Economic Times of India reports the Drug Controller General of India (DCGI), the regulatory body in charge of approving drugs and clinical trials, exists in a state of "limbo" after a series of power struggles and vacancies. The problems are resulting from the formation of New Drug Advisory Committees (NDACs) which were set up to offer regulatory advice to the DCGI, but have instead "over ridden the powers of the drug controller" reports The Economic Times of Indi...