Department of Health and Human Services May 14, 2009 – Federal Register Recent Federal Regulation Documents
Results 1 - 20 of 20
Proposed Collection; Comment Request; The Impact of Continuing Medical Education on Physician Practice
In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Clinical Center, the National Institutes of Health will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget for review and approval.
Determination of Regulatory Review Period for Purposes of Patent Extension; SENSIPAR
The Food and Drug Administration (FDA) has determined the regulatory review period for SENSIPAR 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 human drug product.
Guidance for Industry: Animal Generic Drug User Fees and Fee Waivers and Reductions; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance document for industry (199) entitled ``Animal Generic Drug User Fees and Fee Waivers and Reductions.'' The purpose of this document is to provide guidance to industry on the Animal Generic Drug User Fee Act of 2008 (AGDUFA). FDA is issuing this final guidance document for immediate implementation consistent with the agency's good guidance practices (GGPs). Interested persons may submit comments on agency guidances at any time.
Determination That DECADRON Tablets and Nine Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that the 10 drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
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