Search Results for keywords:"Food and Drug Administration"

The Food and Drug Administration (FDA) has released a draft guideline titled “Evaluating Target Animal Safety and Effectiveness of Antibacterial New Animal Drugs for Bovine Mastitis,” now available for public comment. This guideline offers recommendations for medications that treat bovine mastitis through antibacterial agents administrable by intramammary infusion, but it might also be applicable to other forms or technologies. Individuals are encouraged to provide feedback until February 3, 2025. The document does not establish legal standards but reflects the current FDA views on the topic.

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The Food and Drug Administration (FDA) has released a draft guidance for the industry titled "Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway.”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 The FDA is inviting the public to comment on this draft guidance by March 10, 2025, as part of their ongoing approval process requirements.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) 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 United States Patent and Trademark Office has granted a one-year interim extension for U.S. Patent No. 6,953,476, which belongs to Neovasc Medical Ltd. This patent covers an implantable device called Reducer®, and the extension was needed because the regulatory review by the Food and Drug Administration is expected to take longer than the patent's original expiration date. The extension allows Neovasc more time to prepare while waiting for the FDA's approval process to conclude.

The Food and Drug Administration (FDA) has announced the approval of a product called TREMFYA (guselkumab) using a priority review voucher. This type of voucher is given by the FDA under the Federal Food, Drug, and Cosmetic Act to sponsors with approved treatments for rare pediatric diseases. The approval of TREMFYA, which was finalized on March 20, 2025, met all necessary criteria for using the voucher. Information on both the priority review voucher program and TREMFYA is available on the FDA's website.

The Food and Drug Administration (FDA) has renewed the charter for the Antimicrobial Drugs Advisory Committee until October 7, 2026. This independent advisory group helps the FDA ensure that drugs used to treat infectious diseases are safe and effective. The committee includes 13 voting members with expertise in fields like infectious diseases and internal medicine. The renewal is considered important to support public interest and ensure continued expert advice on drug safety and effectiveness.

The Food and Drug Administration (FDA) is inviting public comments on a proposal to collect certain information related to infectious disease issues in xenotransplantation, which involves transplanting animal organs into humans. This proposed data collection aims to help regulate and ensure the safety of these procedures by maintaining records and specimens for 50 years to prevent disease transmission. Interested parties can submit their comments electronically or in writing by June 30, 2025. The FDA also outlines the estimated burden placed on organizations participating in xenotransplantation studies, including reporting, recordkeeping, and third-party disclosures.

The Food and Drug Administration (FDA) is inviting public comments on a proposed information collection regarding Tropical Disease Priority Review Vouchers. This initiative is part of the Paperwork Reduction Act of 1995, requiring Federal Agencies to seek public feedback on information collections. The priority review vouchers aim to encourage the development of drugs for tropical diseases by offering incentives to drug developers. The deadline for submitting comments electronically or in writing is June 30, 2025.

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.