Department of Health and Human Services March 3, 2020 – Federal Register Recent Federal Regulation Documents
Results 1 - 10 of 10
Determination of Regulatory Review Period for Purposes of Patent Extension; ILUMYA
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ILUMYA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Bone Anchors-Premarket Notification (510(k)) Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Bone AnchorsPremarket Notification (510(k)) Submissions.'' This guidance document provides recommendations for 510(k) submissions for bone anchor (suture anchor) devices. FDA is clarifying and providing current thinking on the recommended content for a bone anchor 510(k) submission, including performance testing recommendations and device description.
Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The guidances identified in this notice were developed using the process described in that guidance.
Determination That NEO TECT KIT (Kit for the Preparation of Technetium TC-99m Depreotide Injection) Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that NEO TECT KIT (Kit for the Preparation of Technetium Tc 99m Depreotide Injection) was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) that refer to the product, if all other legal and regulatory requirements are met.
Preparation for International Cooperation on Cosmetics Regulation Fourteenth Annual Meeting; Public Meeting
The Food and Drug Administration (FDA or we) is announcing the following public meeting entitled ``International Cooperation on Cosmetics Regulation (ICCR)Preparation for ICCR-14 Meeting.'' The purpose of the public meeting is to invite public input on various topics pertaining to the regulation of cosmetics. We may use this input to help us prepare for the ICCR-14 meeting that will be held June 8 to 10, 2020, in Brussels, Belgium.
Meeting of the National Advisory Council for Healthcare Research and Quality
This notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``AHRQ Research Reporting System (ARRS).''
Supplemental Evidence and Data Request on Prehospital Airway Management
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Prehospital Airway Management, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
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