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Zdrowie i gospodarka · 13.04.2011

Agency Information Collection Activities; Proposed Collection; Comment Request; Applications for Food and Drug Administration Approval To Market a New Drug; Postmarketing Reports; Reporting Information About Authorized Generic Drugs

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 the requirements for a New Drug Application (NDA) holder to notify the Agency if an authorized generic drug is marketed by clearly including this information in an easily accessible place in the annual report and by sending a copy of the relevant portion of the annual report to a central contact point in the Agency.

Source: Federal Register — Health and Human ServicesOpen original release →