Department of Health and Human Services January 5, 2005 – Federal Register Recent Federal Regulation Documents
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Annual Comprehensive List of Guidance Documents at the Food and Drug Administration
The Food and Drug Administration (FDA) is publishing its annual comprehensive list of all guidance documents currently in use at the agency. This list is being published under FDA's good guidance practices (GGPs) regulations. It is intended to inform the public of the existence and availability of all of our current guidance documents. It also provides information on guidance documents that have been added or withdrawn in the past year.
Orally Administered Drug Products for Relief of Symptoms Associated With Overindulgence in Food and Drink for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph
The Food and Drug Administration (FDA) is proposing to amend the tentative final monograph (TFM) for over-the-counter (OTC) orally administered drug products for relief of symptoms associated with overindulgence in food and drink to include an additional use for products that contain bismuth subsalicylate as an active ingredient labeled for the relief of symptoms of upset stomach due to overindulgence resulting from food and drink. This proposal is part of FDA's ongoing review of OTC drug products.
Draft Risk Assessment of Streptogramin Resistance in Enterococcus faecium Attributable to the Use of Streptogramins in Animals; Extension of Comment Period
The Food and Drug Administration (FDA) is extending to February 23, 2005, the comment period for the notice that appeared in the Federal Register of November 24, 2004 (69 FR 68384). In the notice, FDA requested comments on a draft risk assessment of the potential impact that food-animal use of streptogramin antimicrobials has on the resistance to chemically similar streptogramins used to treat human enterococcal infections. The agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
International Conference on Harmonisation; Draft Guidances on E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs and S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals; Availability; Reopening of Comment Periods
The Food and Drug Administration (FDA) is reopening until February 18, 2005, the comment periods for the draft guidances entitled ``E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs'' and ``S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals.'' The draft guidances were prepared under the auspices of the International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. FDA published notices of availability of the draft guidances in the Federal Register of September 13, 2004 (69 FR 55163 and 69 FR 55164, respectively). FDA is taking this action in response to requests to extend the comment periods for both draft guidances.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Third-Party Review Under the Food and Drug Administration Modernization Act, Third-Party Premarket Submission Review, and Quality System Inspections Under the United States/European Community Mutual Recognition Agreement
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
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