Department of Health and Human Services February 12, 2018 – Federal Register Recent Federal Regulation Documents
Results 1 - 14 of 14
Packaging, Storage, and Disposal Options To Enhance Opioid Safety-Exploring the Path Forward; Public Workshop; Extension of Comment Period
The Food and Drug Administration (FDA or Agency) is extending the comment period for the notice announcing the public workshop entitled ``Packaging, Storage, and Disposal Options To Enhance Opioid SafetyExploring the Path Forward'' that appeared in the Federal Register on October 31, 2017, and was held on December 11-12, 2017. That notice requested comments by February 12, 2018; FDA is extending the comment period until March 16, 2018, in response to requests for an extension to allow interested persons additional time to submit comments.
Training Program for Regulatory Project Managers; Information Available to Industry
The Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research (CDER) is announcing the continuation of the Regulatory Project Management Site Tours and Regulatory Interaction Program (the Site Tours Program). The purpose of this document is to invite pharmaceutical companies interested in participating in this program to contact CDER.
Determination of Regulatory Review Period for Purposes of Patent Extension; IMBRUVICA
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for IMBRUVICA 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 the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; DALVANCE
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for DALVANCE 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 the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; GILOTRIF
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for GILOTRIF 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 the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Content and Format of Labeling for Human Prescription Drugs and Biological Products; Requirements for Pregnancy and Lactation Labeling
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.
Determination of Regulatory Review Period for Purposes of Patent Extension; BELSOMRA
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BELSOMRA 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 the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; BRAVECTO
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BRAVECTO 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 U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that animal drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; AKYNZEO
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for AKYNZEO 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 the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Low Income Levels Used for Various Health Professions and Nursing Programs Authorized in Titles III, VII, and VIII of the Public Health Service Act
HRSA is updating income levels used to identify a ``low income family'' for the purpose of determining eligibility for programs that provide health professions and nursing training to individuals from disadvantaged backgrounds. These various programs are authorized in Titles III, VII, and VIII of the Public Health Service Act.
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