Search Results for agency_names:"Food and Drug Administration"

The Department of Health and Human Services and the Food and Drug Administration (FDA) are proposing to permanently waive certain premarket notification requirements for specific medical devices. This action follows temporary waivers provided during the COVID-19 pandemic to make medical devices more accessible. The proposal includes making seven class I devices and 84 class II devices permanently exempt from the 510(k) premarket notification requirement, which typically involves a costly and time-consuming process. The public is invited to comment on the proposed exemptions and suggest improvements to the regulatory system concerning medical devices.

The Food and Drug Administration (FDA) has proposed a collection of information regarding laboratory accreditation for food analysis and submitted it to the Office of Management and Budget (OMB) for review under the Paperwork Reduction Act. The accreditation program aims to ensure food safety by allowing laboratories accredited by recognized bodies to conduct food testing. This program is voluntary, and the FDA estimates a decrease in the number of respondents and burden hours compared to the previous collection data. The public can submit comments by January 21, 2025, through the specified online portal.

The Food and Drug Administration (FDA) is seeking public comments on a proposed information collection about foodborne illness risk factors in specific foodservice settings. This project continues a study that initially ran from 1998 to 2008; it aims to identify common factors that contribute to foodborne illnesses in retail food establishments. The study will guide the development of safety initiatives and policies and assist regulators across the United States. Interested parties have until April 19, 2021, to submit their comments electronically or by mail.

The Food and Drug Administration (FDA) is seeking public comments on a concept paper regarding the use of medically important antimicrobial drugs in animal feed. The paper suggests a framework for how drug sponsors can define the duration of use for these drugs in food-producing animals, aiming to prevent antimicrobial resistance and promote public health. The FDA is particularly interested in input on the timelines and processes proposed in the paper and hopes to use the feedback to create draft guidance. Comments can be submitted electronically or in writing by April 12, 2021.

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 Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) have issued a notice about two requests for proposals that were initially published on September 24, 2020. These proposals involve the reimportation of insulin and the personal importation of prescription drugs. The notice updates these proposals to include revised versions in the Federal Register. Responses to the proposals can be submitted via email and will be reviewed on a rolling basis.

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) has submitted a proposal to the Office of Management and Budget (OMB) for review, seeking to extend the collection of information related to drug, biological product, and device applications under the Paperwork Reduction Act. This involves certifications that accompany these submissions to ensure compliance with legal standards, including listing data for clinical trials in a registry. The FDA estimates that it will take approximately 15 to 45 minutes to complete the necessary certification forms, depending on the type of application, and aims to simplify compliance for sponsors and applicants. No public comments were received on this proposal when it was initially published.

The Food Safety and Inspection Service (FSIS) and the Food and Drug Administration (FDA) are seeking public input regarding food date labeling. They aim to gather information on industry practices, consumer perceptions, and the impact of date labels on food waste. Both agencies are concerned that inconsistent labeling terms like "Sell By" and "Use By" may confuse consumers, leading to unnecessary food waste. They encourage the use of the phrase "Best if Used By" to reduce confusion and are asking for public comments to guide future policies by February 3, 2025.

The Food and Drug Administration (FDA) is withdrawing approval for four abbreviated new drug applications (ANDAs) because the manufacturers informed the FDA that these drugs are no longer being sold. The manufacturers requested this action and have given up their right to a hearing. As of April 14, 2025, these drugs cannot legally be sold or introduced into interstate commerce in the U.S. unless they have an approved application. However, any remaining stock of these drugs can be used until they expire or are sold out.