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The Food and Drug Administration (FDA) has announced the release of a report titled "Food and Drug Administration Report and Plan on Best Practices for Guidance." This report, requested by the Consolidated Appropriations Act, 2023, outlines best practices for creating, prioritizing, and using guidance documents efficiently. The FDA gathered and considered public feedback on a draft report published in December 2023, which led to this final version. The report aims to enhance transparency, improve regulatory processes, and support the development of new products for public health.

The Food and Drug Administration (FDA) is seeking public feedback on a proposed information collection regarding prescription drug labeling. This information is being reviewed by the Office of Management and Budget (OMB) as required by the Paperwork Reduction Act. The proposal primarily concerns updating and revising regulations for drug labeling, including safety labeling changes and medical gas container labeling. The FDA is inviting comments until March 5, 2025, and offers guidance for companies required to comply with these labeling standards.

The Food and Drug Administration (FDA) is extending the comment period for gathering information on industry practices related to poppy seeds. This includes cultivation, processing, and methods to reduce opiate alkaloid levels in poppy seeds. Due to requests for more time, the FDA is allowing an additional 60 days for comments, with submissions acceptable until June 16, 2025. This information will help the FDA decide if any actions are needed to ensure that poppy seed products are safe for consumption.

The Food and Drug Administration (FDA) has set January 1, 2024, as the uniform compliance date for food labeling regulations that were published between January 1, 2021, and December 31, 2022. This means any new food labeling rules released during this timeframe must be followed by the start of 2024 to reduce the economic impact of labeling changes on the food industry. The FDA states that while these regulations don't immediately introduce new costs, they allow businesses time to adjust their labeling practices. The rule also specifies that special circumstances may justify a different compliance date, which will be detailed as needed.

The Food and Drug Administration (FDA), part of the U.S. Department of Health and Human Services, announced that the Office of Management and Budget (OMB) has approved a new information collection called "Shortages Data Collection" under the Paperwork Reduction Act. This approval, which includes the assignment of OMB control number 0910-0491, allows the FDA to collect data related to shortages until October 31, 2027. The purpose of this data collection is to help the FDA better understand and manage supply shortages.

The Food and Drug Administration (FDA) is asking the public to comment on its proposed updates to how it collects information from tobacco product establishments. These changes aim to streamline the registration and listing process for such establishments and involve revisions to forms and the use of an improved electronic portal. The updates are also expected to make the registration process simpler and more efficient. The public can submit their comments online or through mail until March 18, 2025.

The Food and Drug Administration (FDA) has released new guidance aimed at reducing the risk of disease transmission caused by sepsis in human cell and tissue products. This guidance is designed to help organizations that make donor eligibility decisions by recommending practices to lower infection risks. The FDA issued this guidance immediately due to urgent health concerns, updating previous recommendations from 2007. The guidance reflects the FDA's current viewpoints but does not impose any legal obligations.

The Food and Drug Administration (FDA) has calculated the regulatory review period for the human biological product ROCTAVIAN. This action is in relation to a request for patent term extension submitted to the U.S. Patent and Trademark Office by BioMarin Pharmaceutical, Inc. The total review period is 2,101 days, divided into 816 days for testing and 1,285 days for approval. The FDA encourages anyone who believes the dates are incorrect to submit comments or petitions by specified deadlines for consideration.

The Food and Drug Administration (FDA) is proposing a new rule to set a maximum nicotine level in cigarettes and other combusted tobacco products. This measure aims to decrease the addictiveness of these products, making it easier for people who want to quit to do so, and to prevent youth from becoming addicted. The rule is expected to benefit public health by reducing the number of individuals who start smoking or continue smoking over time. The proposal could potentially improve health outcomes by reducing the overall harmful effects of tobacco addiction.

The Food and Drug Administration (FDA) has announced the revocation of Emergency Use Authorizations (EUAs) for three COVID-19 tests developed by Beckman Coulter, Inc., including the Access SARS-CoV-2 IgG, IgM, and IgG II tests. This action was taken upon the request of Beckman Coulter, who also decided to stop the distribution of these tests as of January 1, 2025. The FDA concluded that revoking these authorizations is necessary to protect public health and safety. The revocation became effective on January 8, 2025, with detailed explanations provided for each decision.