Department of Health and Human Services March 27, 2007 – Federal Register Recent Federal Regulation Documents
Results 1 - 7 of 7
Draft Guidance for Industry and Food and Drug Administration Staff; Modifications to Devices Subject to Premarket Approval-The Premarket Approval Supplement Decision-Making Process; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Modifications to Devices Subject to Premarket Approval (PMA)The PMA Supplement Decision-Making Process.'' This draft guidance is intended to help the regulated industry determine whether submitting a PMA supplement or other notification to FDA is required for class III devices subject to PMA. This draft guidance is not final nor is it in effect at this time.
Agency Information Collection Activities; Proposed Collection; Comment Request; Focus Groups as Used by the Food and Drug Administration
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 focus groups as used by FDA to gauge public opinion.
Determination of Regulatory Review Period for Purposes of Patent Extension; A180
The Food and Drug Administration (FDA) has determined the regulatory review period for A180 and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that animal drug product.
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