Search Results for keywords:"health regulations"

The Food and Drug Administration (FDA) announced the withdrawal of a rule that was originally published on September 20, 2024. This rule was intended to amend regulations regarding regulatory hearings before the agency. However, after receiving a significant number of adverse comments from the public, the FDA decided not to proceed with the changes. The rule is officially withdrawn as of January 17, 2025.

The Centers for Medicare & Medicaid Services (CMS) has announced a chance for the public to comment on its plan to collect information under the Paperwork Reduction Act of 1995. This involves revising and extending various information collection activities, like Medicare Part A enrollment applications and disclosures under the Mental Health Parity and Addiction Equity Act. The information gathered helps ensure proper agency functions and improve automated data collection. Public comments are invited by March 15, 2021, to address the necessity and impact of these collections.

The Food and Drug Administration (FDA) is announcing a draft guidance for industry on creating sanitation programs for low-moisture, ready-to-eat foods to prevent pathogen contamination.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.

The Food and Drug Administration (FDA) has released a draft guidance for industry on the process of notifying them about a permanent discontinuance or an interruption in the manufacture of infant formula. This guidance aims to assist those in the infant formula industry in complying with notification requirements to the FDA, as mandated under the Federal Food, Drug, and Cosmetic Act. The guidance outlines how and when manufacturers should notify the FDA in order to avoid potential disruptions in supply. The public is invited to submit comments on the draft guidance until February 18, 2025, and on the proposed collection of information by February 3, 2025.

The Food and Drug Administration (FDA) is seeking public comments on a proposed information collection related to the registration of drug producers and the listing of drugs in commercial distribution. This effort supports the implementation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and aims to maintain up-to-date drug information to ensure public health. Key updates include exemptions for certain biological products under new guidelines resulting from the CARES Act and recommendations for emergency planning to maintain drug supply. The public can provide feedback by January 21, 2025, through the specified OMB website link.

The Food and Drug Administration (FDA) is hosting a joint public advisory committee meeting on February 5, 2025. This meeting involves the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. The focus will be on discussing the outcomes of studies related to the risks associated with long-term use of extended-release/long-acting opioid analgesics. The FDA has opened a public comment docket, which will close on February 4, 2025, allowing individuals to submit their views electronically or by mail.