Department of Health and Human Services April 20, 2009 – Federal Register Recent Federal Regulation Documents
Results 1 - 9 of 9
Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting
The Food and Drug Administration (FDA) is announcing a public meeting to obtain input on developing Risk Evaluation and Mitigation Strategies (REMS) for certain opioid drugs. The REMS would be intended to ensure that the benefits of these drugs continue to outweigh certain risks. The agency has long been concerned about adverse events associated with this class of drug and has taken steps in cooperation
Agency Information Collection Activities; Proposed Collection; Comment Request; Draft Guidance, Emergency Use Authorization of Medical Products
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 proposed extension of the collection of information related to emergency use authorizations (EUAs) by the agency.
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