CSIR-Central Drug Research Institute, Lucknow, a premier Institute under Council of Scientific and Industrial Research (CSIR), is involved in multidisciplinary R&D programs of both basic and applied nature. CSIR-CDRI is a pioneer biomedical research organization in India and has the infrastructure and expertise to develop a drug from conceptualization to commercialization.
U.S. Food and Drug Administration issued a proposed rule to set forth requirements related to the content, format and FDA’s review and communications procedures for premarket tobacco product applications (PMTAs) as part of the agency’s continued commitment to its oversight of e-cigarettes and other tobacco products. When finalized, this proposed rule will help to ensure that PMTAs contain sufficient information for evaluation such as details regarding the physical aspects of a tobacco product and information on the product’s potential public health benefits and harms. It also would codify the procedures by which the agency would review PMTAs and establish the requirements for manufacturers to maintain records related to the legal marketing status of their tobacco products.
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