Department of Health and Human Services November 8, 2011 – Federal Register Recent Federal Regulation Documents
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Gayle Rothenberg: Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Gayle Rothenberg, MD, from providing services in any capacity to a person that has an approved or pending drug product application. We base this order on a finding that Dr. Rothenberg was convicted of felonies under Federal law for conduct relating to the regulation of a drug product under the FD&C Act. Dr. Rothenberg was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Rothenberg failed to respond. Dr. Rothenberg's failure to respond constitutes a waiver of her right to a hearing concerning this action.
Draft Guidance for Industry and Food and Drug Administration Staff; 510(k) Device Modifications: Deciding When To Submit a 510(k) for a Change to an Existing Device; Availability; Reopening of Comment Period
The Food and Drug Administration (FDA) is reopening until November 28, 2011, the comment period for the notice entitled ``Draft Guidance for Industry and Food and Drug Administration Staff; 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device; Availability,'' that appeared in the Federal Register of July 27, 2011 (76 FR 44935). In that document, FDA announced the availability of a draft guidance for industry and FDA staff and requested comments. The Agency is taking this action to allow interested persons additional time to submit comments.
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