Search Results for keywords:"Food and Drug Administration"

The Food and Drug Administration (FDA) has made available a final guidance document titled "Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act." This guidance updates a previous version and includes a list known as the 506J Device List, which outlines device product codes that manufacturers must notify the FDA about if they stop production. The document clarifies that manufacturers can also voluntarily notify the FDA of any supply chain issues, regardless of public health emergencies. This guidance aims to facilitate continuous device supply and prevent shortages.

The Food and Drug Administration (FDA) is notifying the public about a proposed collection of information related to the extralabel use of drugs in animals that has been submitted to the Office of Management and Budget (OMB) for review. This request is part of the Paperwork Reduction Act of 1995 process. The proposal involves the FDA's ability to set safety levels for drug residues and require methods to detect them. Public comments on this collection of information can be submitted until February 12, 2021.

The Food and Drug Administration (FDA) announced the availability of its annual update on the Susceptibility Test Interpretive Criteria web page, part of procedures under the 21st Century Cures Act. This web page lists standards used to determine the effectiveness of antimicrobial drugs, making it easier for device makers to update their testing products. The FDA is requesting public comments and will update the standards based on feedback. The agency recognizes new standards and withdraws others, such as ones from the Clinical and Laboratory Standards Institute, as part of this ongoing update process.

The Food and Drug Administration (FDA) is proposing to reject the new drug application from Vanda Pharmaceuticals for TRADIPITANT capsules, intended to treat nausea in gastroparesis. The application was found lacking as it did not provide substantial evidence of the drug’s effectiveness and safety based on submitted studies and data. Vanda has the option to request a hearing to contest this decision, though they must address all the identified deficiencies. If no hearing request is filed, or if it is not deemed substantial, the FDA will officially deny the application.

The Food and Drug Administration (FDA) has decided to revoke the use of the color additive FD&C Red No. 3 in foods and ingested drugs. This decision was based on evidence showing that FD&C Red No. 3 can cause cancer in male rats, which under the law, makes it unsafe. Although the risk to humans is considered low, the FDA is compelled by law to remove this additive because it has been linked to cancer in animals. The order will take effect on January 15, 2027, but objections can be submitted until February 18, 2025, if anyone is adversely affected by this ruling.

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) has released a notice regarding updates to the list of standards used in assessing medical devices, known as the "FDA Recognized Consensus Standards." These updates, called "Recognition List Number: 063," help manufacturers who wish to align their products with these standards. People can submit comments or suggestions for additional standards anytime, and the FDA keeps a database of the recognized standards available online. The updated list of standards is effective from March 20, 2025.

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) has determined that the drug VIBRAMYCIN (doxycycline) for oral suspension was not taken off the market due to safety or effectiveness concerns. This decision allows the FDA to continue approving generic versions of this medication as long as they meet legal and regulatory criteria. VIBRAMYCIN is included in the “Discontinued Drug Product List” because it was removed from sale for reasons unrelated to safety or effectiveness. If necessary, the FDA may require updates to the drug’s labeling to align with current standards.

The Food and Drug Administration (FDA) has announced the release of a final guidance document titled "Mouse Embryo Assay for Assisted Reproduction Technology Devices." This guidance provides recommendations on conducting the mouse embryo assay (MEA), which is used to evaluate the potential for embryotoxicity of devices that come into contact with gametes and/or embryos. The FDA has revised the guidance based on public comments and has made several technical clarifications. The document emphasizes that following FDA guidelines is not mandatory and alternative approaches are acceptable if they meet relevant requirements.