Department of Health and Human Services September 6, 2017 – Federal Register Recent Federal Regulation Documents
Results 1 - 11 of 11
Determination That RITALIN LA (Methylphenidate Hydrochloride) Extended-Release Capsules, 60 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that RITALIN LA (methylphenidate hydrochloride) extended- release capsules, 60 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for methylphenidate hydrochloride extended-release capsules, 60 mg, if all other legal and regulatory requirements are met.
Determination That GYNOREST (Dydrogesterone) Oral Tablets, 5 Milligrams and 10 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that GYNOREST (dydrogesterone) oral tablets, 5 milligrams (mg) and 10 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for GYNOREST (dydrogesterone) oral tablets, 5 mg and 10 mg, if all other legal and regulatory requirements are met.
Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices.'' FDA is issuing this guidance to assist industry and FDA staff in identifying specific considerations related to the ability of electronic medical devices to safely and effectively exchange and use exchanged information. This document highlights considerations that should be included in the development and design of interoperable medical devices and provides recommendations for the content of premarket submissions and labeling for such devices.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on Mobile Proximity Initial User Feedback information collection project.
B. Braun Medical, Inc.; Withdrawal of Approval of Three New Drug Applications and One Abbreviated New Drug Application; Correction
The Food and Drug Administration (FDA) is correcting a document entitled ``B. Braun Medical, Inc.; Withdrawal of Approval of Three New Drug Applications and One Abbreviated New Drug Application'' that appeared in the Federal Register of August 3, 2017 (82 FR 36150). The document was published with the incorrect docket number. This document corrects that error.
Development of a List of Pre-Dietary Supplement Health and Education Act Dietary Ingredients; Public Meeting; Request for Comments
The Food and Drug Administration (FDA or we) is announcing the following public meeting entitled ``Development of a List of Pre-DSHEA Dietary Ingredients.'' The purpose of the meeting is to give interested stakeholders an opportunity to discuss issues related to FDA's future development of such a list.
Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: What You Need To Know About the Food and Drug Administration Regulation; Small Entity Compliance Guide; Availability
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled ``Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: What You Need to Know About the FDA Regulation: Small Entity Compliance Guide.'' The small entity compliance guide (SECG) is intended to help small entities comply with the final rule entitled ``Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.''
Food and Drug Administration, Center for Drug Evaluation and Research Rare Diseases Public Workshop: Strategies, Tools, and Best Practices for Effective Advocacy in Rare Diseases Drug Development
The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), is sponsoring a public workshop entitled ``CDER Rare Diseases Public Workshop: Strategies, Tools, and Best Practices for Effective Advocacy in Rare Diseases Drug Development.'' This public workshop builds upon previous CDER patient advocacy public workshops and is primarily for the rare disease community to help them effectively understand what FDA needs to enhance drug development. This effort is consistent with FDA's efforts to support the integration of patient experience in drug development programs, including through implementation of the ``Patient-Focused Drug Development'' provisions of the 21st Century Cures Act (Cures Act). This public workshop will include case studies demonstrating the beneficial overlap of effective advocacy techniques and FDA regulations in rare disease drug development.
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