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The Food and Drug Administration (FDA) has announced the regulatory review period for NEXOBRID, a product used for eschar removal in adults with certain types of burns. This review period is relevant to an application for patent term extension submitted to the U.S. Patent and Trademark Office (USPTO) by MediWound, Ltd. The FDA determined that the total regulatory review period for NEXOBRID was 7,427 days, with a request for a 5-year patent extension being made. The public can submit comments on this determination until February 28, 2025, and may petition the FDA to review whether the applicant acted with due diligence during this period by June 30, 2025.

The Food and Drug Administration (FDA) is setting January 1, 2028, as the compliance date for new food labeling regulations published between January 1, 2025, and December 31, 2026. This decision helps reduce the economic impact on the food industry by allowing time to adjust to the new labeling requirements. The FDA has not made any environmental impact assessments, as this action is considered non-significant in that regard. The announcement is effective immediately, but public comments can be submitted until March 3, 2025.

The Food and Drug Administration (FDA) will hold a public advisory committee meeting for the Circulatory System Devices Panel on February 17, 2021. The meeting, which will be conducted online due to the COVID-19 pandemic, will cover the premarket approval application for the Lutonix 014 Drug Coated Balloon Percutaneous Transluminal Angioplasty catheter. The public is welcome to attend the meeting and can submit written or oral presentations by specified deadlines. Further information, including meeting materials and the teleconference link, will be available on the FDA’s website.

The Food and Drug Administration (FDA) has announced the issuance of a priority review voucher to SpringWorks Therapeutics, Inc. for their drug GOMEKLI (mirdametinib). This drug is used to treat adults and children 2 years and older who have neurofibromatosis type 1 with symptomatic plexiform neurofibromas. The priority review voucher is awarded under the Federal Food, Drug, and Cosmetic Act to incentivize companies to develop treatments for rare pediatric diseases. The notice was officially filed on March 12, 2025.

The Food and Drug Administration (FDA) has announced the availability of draft guidance for devices that use artificial intelligence (AI)-enabled software functions. This draft guidance, once finalized, will give recommendations for what should be included in marketing submissions, focusing on safety and effectiveness. It suggests a total product lifecycle (TPLC) approach, which considers the design, development, and implementation stages of AI-enabled devices. Public comments on this draft are sought to ensure that FDA’s guidance aligns with the fast-evolving field of AI and adequately addresses performance and risk concerns.

The Food and Drug Administration (FDA) is inviting the public to comment on a proposed collection of information related to its Generic Drug User Fee Program. This proposal is part of fulfilling requirements under the Paperwork Reduction Act, which mandates a 60-day public comment period for proposed information collections. Comments can be submitted online through https://www.regulations.gov or via mail by March 17, 2025. The FDA seeks feedback on the necessity, accuracy, and methods of the information collection, and aims to support the implementation of its program through the information gathered.

The Food and Drug Administration (FDA) is collecting information regarding humanitarian use devices (HUDs), which are medical devices meant for conditions affecting fewer than 8,000 people in the U.S. The FDA seeks public comments on this information collection by March 26, 2021, to help decide whether these devices should be exempt from certain effectiveness requirements. This effort is in accordance with the Paperwork Reduction Act and aims to ensure that those with rare conditions have access to necessary medical devices without significant safety risks. Additionally, the FDA updated estimates of the time and resources needed for this data collection to reflect more current information.

The Food and Drug Administration (FDA) has released draft guidance to accelerate the approval process for drugs and biologics meant for serious or life-threatening conditions. This expedited program aims to quickly develop and review drugs that address unmet medical needs. The draft outlines the criteria for accelerated approval, including surrogate endpoints and confirmatory trials, and introduces procedures for rapidly withdrawing approvals if necessary. The public can submit comments on this draft by February 4, 2025, and share thoughts on the expedited withdrawal procedures and other aspects of the accelerated approval process.

The Food and Drug Administration (FDA) is asking for industry input about the growth, harvesting, processing, and distribution of poppy seeds, specifically focusing on practices that minimize their opiate alkaloid content. This request for information is due to reports of health issues linked to poppy seed products, including cases where homemade "poppy seed tea" has been connected to serious harm and deaths. The FDA seeks to understand current practices and consider possible future actions to ensure that poppy seed products are safe for consumption. Public comments on this matter are invited until April 15, 2025, through the Federal eRulemaking Portal or via written submissions.

The Food and Drug Administration (FDA) has released a draft guidance document titled "Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)." This document provides general advice on evaluating donor eligibility, including screening and testing procedures. It also updates existing guidelines and plans to introduce additional guidance to help minimize communicable disease risks from donors. Public feedback on these recommendations can be submitted electronically or in writing until February 6, 2025.