Search Results for keywords:"Food and Drug Administration"

The Food and Drug Administration (FDA) has released a draft guidance for the industry titled "Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway.” This guidance is aimed at describing how the FDA interprets the term "underway" in relation to confirmatory drug trials required after a drug has been granted accelerated approval. These trials are crucial for verifying the drug's effects on serious health conditions. The FDA is inviting the public to comment on this draft guidance by March 10, 2025, as part of their ongoing approval process requirements.

The Food and Drug Administration (FDA) issued a rule regarding nonprescription drugs that require additional conditions for safe use. Originally set to take effect on January 27, 2025, the rule has been delayed twice and is now effective on May 27, 2025, due to a review process triggered by a presidential memorandum. The new rule establishes specific requirements for drug applications, labeling, and reporting related to these nonprescription drugs. The FDA intends to use this extra time for a thorough review, as immediate public input was deemed impractical and potentially against public interests, to ensure that entities affected by the rule have sufficient time to adjust their compliance strategies.

The Food and Drug Administration (FDA) is withdrawing approval for 18 new drug applications because the companies that made them have told the FDA that they are no longer selling these drugs. The companies also asked the FDA to withdraw their drug approvals and agreed not to have a hearing about it. This means that starting from May 9, 2025, selling these drugs without approval would be against the law. However, any remaining stock of these drugs can still be sold until they are all gone, expire, or otherwise become non-compliant.

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) is seeking public comments on the collection of information related to the Interstate Shellfish Dealer's Certificate and participation in the National Shellfish Sanitation Program (NSSP). Under the Paperwork Reduction Act of 1995, federal agencies like the FDA must announce proposed information collections in the Federal Register and allow a 60-day comment period. This information helps ensure the safety of shellfish by involving state and international regulators in monitoring shellfish waters and certifying dealers. The FDA is also revising its information collection to include data samples and analytical results from shellfish to ensure they are safe for consumption and meet U.S. standards for export.

The Food and Drug Administration (FDA) is requesting public comments on the National Antimicrobial Resistance Monitoring System (NARMS) 2026-2030 Strategic Plan. The FDA aims to gather input to develop a draft plan, which will be discussed in a public meeting scheduled for spring 2025. They are seeking feedback on how data from NARMS is used, what additional information might be valuable, and suggestions for monitoring antimicrobial resistance within the One Health framework. Comments can be submitted electronically or in writing until March 26, 2025.

The Food and Drug Administration (FDA) has announced that they have accepted a petition from Impossible Foods, Inc. to change the rules about color additives. The proposal is to allow soy leghemoglobin to be used as a color additive in plant-based meat, poultry, and fish products, including both ground and whole cut varieties. This petition, identified as CAP 5C0336, claims to be exempt from certain environmental assessments since the substance is meant to stay in food and not replace any macronutrients. The FDA will determine if such an exclusion is appropriate, or else they will require a detailed environmental review.

The Food and Drug Administration (FDA) is renewing the Technical Electronic Product Radiation Safety Standards Committee for another two years, with the new charter effective until December 24, 2022. This committee provides advice to the FDA on setting standards for radiation emissions from electronic products. The committee includes 15 voting members, selected for their expertise in science or engineering related to radiation safety. The renewal is in the public interest to ensure the safeguarding of health and safety through proper regulatory standards.

The Food and Drug Administration (FDA) is announcing that it has submitted a proposed information collection to the Office of Management and Budget (OMB) for review under the Paperwork Reduction Act of 1995. This collection aims to support FDA's communication efforts regarding drug products by understanding public attitudes and beliefs through interviews and surveys. The FDA plans to conduct approximately 45 communication studies annually to develop effective communication messages related to drug products. No public comments were received on the proposed collection during a previous notice period.

The Food and Drug Administration (FDA) has determined the regulatory review period for a human biologic product named OMISIRGE, which is used for treating certain blood cancers. The review period, which is 4,563 days long, involves a testing phase and an approval phase and influences the potential extension of the product's patent. The FDA's decision follows an application by Gamida Cell Ltd. for patent extension, and the public can provide comments or request further determinations by specified deadlines.