Search Results for agency_names:"Food and Drug Administration"

The Food and Drug Administration (FDA) is asking for public feedback on gathering certain data about reprocessed, single-use medical devices under the Paperwork Reduction Act. This public comment period lasts for 60 days, ending on April 26, 2021. The FDA wants to know if the information collection is necessary, how accurate their burden estimates are, and if there are better ways to collect data. This initiative aims to ensure that reprocessed devices clearly show the manufacturer's name or symbol to prevent misbranding, as required by federal law.

The Food and Drug Administration (FDA) has released a draft report titled "Best Practices for FDA Communication with Interested Parties" and is asking for public feedback. This report is part of a response to the Consolidated Appropriations Act of 2023, which requires the FDA to review and improve its communication methods with medical product sponsors and other external parties. The draft includes current communication practices and explores new, innovative strategies used during the COVID-19 pandemic. People can provide feedback on this draft report until February 3, 2025, through electronic or written submissions.

The Department of Health and Human Services (HHS) has issued a final rule that requires its regulations to be reviewed periodically, with most regulations set to expire automatically every ten years unless reviewed. This is intended to ensure that regulations stay up-to-date and relevant. The final rule also includes processes for public comments and specifies the criteria for reviews, which include assessing whether the regulations significantly impact small entities, and if they are still necessary or need amendments. Certain regulations, such as those mandated by federal law and the annual Medicare payment update rules, are exempt from these reviews.

The Food and Drug Administration (FDA) has announced it will transfer regulatory responsibility for medical maggots and medicinal leeches from the Center for Devices and Radiological Health (CDRH) to the Center for Biologics Evaluation and Research (CBER), effective December 30, 2024. This decision was made because these products are living organisms, and CBER is more suited to regulate such products. The transfer only affects which FDA Center will oversee these products and does not change any existing requirements. After the transfer date, all submissions related to these products should be directed to CBER.

The Food and Drug Administration (FDA) has released new guidelines for companies submitting information electronically related to drug and biologic license applications. This guidance helps ensure that data is submitted in a standardized format, which the FDA uses to plan and conduct inspections of research sites, known as Bioresearch Monitoring (BIMO) inspections. The guidance also clarifies which trials need to include certain information, aiming to enhance the FDA's inspection process for safety and efficacy claims in drug applications. Additionally, the guidance addresses previous technical issues and provides updated instructions for submissions under specific FDA regulations.

The Food and Drug Administration (FDA) has reorganized its Center for Drug Evaluation and Research (CDER), specifically within the Office of Medical Policy (OMP), which was approved by the Secretary of Health and Human Services on November 19, 2024. This reorganization aims to improve the FDA's ability to conduct its public health mission by enhancing its capacity to innovate in clinical trials, using tools such as Artificial Intelligence (AI) and Digital Health Technologies (DHTs). The Division of Clinical Trial Quality has been renamed to the Division of Clinical Innovations to support this focus. This restructuring is intended to foster collaboration, attract a diverse workforce, and modernize policy development to guide innovative drug development practices.

The Food and Drug Administration (FDA) announced that certain drug products, including ARALEN (Chloroquine Phosphate) oral tablets, were not removed from the market due to safety or effectiveness issues. This means that the FDA will continue to allow the approval of generic versions of these drugs through abbreviated new drug applications (ANDAs). The drugs will remain listed in the FDA's "Discontinued Drug Product List" in the Orange Book, indicating that their discontinuation was for reasons other than safety or effectiveness. If necessary, the FDA may request updates to the labels of these drugs to meet current standards.

The Food and Drug Administration (FDA) is announcing a public advisory committee meeting for the Vaccines and Related Biological Products Advisory Committee. The committee will discuss and provide recommendations regarding the strains to be included in the influenza vaccines for the 2021-2022 flu season. The meeting will be held online on March 5, 2021, from 9 a.m. to 3:30 p.m. Eastern Time, due to the COVID-19 pandemic. Public comments can be submitted until March 4, 2021, and those received by February 24 will be shared with the committee before the meeting.

The Food and Drug Administration (FDA) is seeking information on the production methods and ingredients used in making high-protein yogurt, including Greek yogurt, due to discrepancies with existing yogurt identity standards. This request aims to understand if different standards are needed to ensure consumer honesty and fair dealing, considering innovations and practices in the yogurt industry. The public can submit comments electronically or in writing until April 15, 2025. The FDA is particularly interested in consumer perceptions, industry practices, and the labeling of these high-protein yogurt products.

The Food and Drug Administration (FDA) is announcing a draft guidance for industry on creating sanitation programs for low-moisture, ready-to-eat foods to prevent pathogen contamination. This guidance also advises on corrective actions to take if contamination occurs. It applies to various foods like powdered infant formula and peanut butter and aims to help manufacturers maintain a sanitary food supply. Stakeholders can submit comments on the draft by May 7, 2025, to be considered before finalizing the guidance.