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Zdrowie i gospodarka · 25.08.2005

Agency Information Collection Activities; Proposed Collection; Comment Request; Financial Disclosure by Clinical Investigators

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information requiring the sponsor of any drug, biologic, or device marketing application to certify to the absence of clinical investigators and/or disclose those financial interests as required, when covered clinical studies are submitted to FDA in support of product marketing.

Source: Federal Register — Food and Drug AdministrationOpen original release →