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Zdrowie i gospodarka · 5.09.2019

Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on E6(R2) Good Clinical Practice; International Council for Harmonisation; Integrated Addendum to International Council for Harmonisation E6(R1)

The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (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 collection recommendations found in Agency guidance pertaining to the development of a system to manage quality as well as information to include in a clinical study report about the quality management approach.

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