Department of Health and Human Services January 2, 2008 – Federal Register Recent Federal Regulation Documents
Results 1 - 10 of 10
Request for Information and Comments on Research That Involves Adult Individuals With Impaired Decision-Making Capacity
On September 5, 2007, the Office for Human Research Protections, Office of Public Health and Science, Office of the Secretary, Department of Health and Human Services (HHS) issued a notice in the Federal Register (Vol. 72, No. 171, pages 5096650970) seeking information and comments about whether guidance or additional regulations are needed to adequately protect adult individuals with impaired decision-making capacity who are potential subjects in research. A 90-day comment period was established upon publication of that notice. The purpose of this notice is to inform all interested parties that the comment period originally identified in the September 5, 2007 Federal Register has been extended for forty one days, in order to maximize the opportunity for interested individuals and organizations to provide information and comments to HHS on this topic.
Guidance for Industry and Food and Drug Administration; Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements.'' The purpose of this guidance document is to recommend an interactive premarket review process for these submissions that is designed to expedite FDA's review of device applications while continuing to assure device safety and effectiveness, in accordance with the goals of the Food and Drug Administration Amendments Act of 2007 (FDAAA).
Draft Guidance for Industry on Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act.'' This draft guidance is intended to assist industry in complying with the labeling requirements for nonprescription (over-the-counter (OTC)) human drugs marketed without an approved application established by the Dietary Supplement and Nonprescription Drug Consumer Protection Act. Separate guidance, issued by the Center for Food Safety and Applied Nutrition on labeling requirements for dietary supplements, is announced elsewhere in this issue of the Federal Register.
Draft Guidance for Industry: Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act.'' This draft guidance is intended to assist the dietary supplement industry in complying with the labeling requirements prescribed for dietary supplement manufacturers, packers, and distributors by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (the DSNDCPA). Separate guidance, issued by the Center for Drug Evaluation and Research on labeling requirements for nonprescription (over-the-counter) human drugs marketed without an approved application, is announced elsewhere in this issue of the Federal Register.
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