Compliance, Consumer Trends, Regulatory Information 16 Jan 2025 fda, cannabis, regulations, cbd, veterinary medicine, animal health

🐾FDA Seeks Input on Cannabis-Derived Products in Veterinary Use

The Food and Drug Administration (FDA, the Agency, or we) is soliciting comments from the public, particularly veterinarians, related to the use of cannabis-derived products (CDPs) in animals, with an emphasis on cannabidiol (CBD) products and general trends associated with those products, including information about: usage trends (e.g., product selection, indications, etc.), quality standards, benefits of use, potential drug interactions, adverse events and safety problems, and toxicological concerns. This information will enhance the Center for Veterinary Medicine's (CVM's) knowledge of potential safety signals associated with these products, in addition to aiding our understanding of veterinarians' experiences related to the use of CDPs for their animal patients.

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Regulatory Compliance, Financial Impact 16 Jan 2025 compliance, regulation, administrative practice and procedure, fda, public health, labeling, tobacco, nicotine, smoking, nicotine standard

🚬Proposed Nicotine Yield Regulations

The Food and Drug Administration (FDA, the Agency, or we) is proposing a tobacco product standard that would regulate nicotine yield by establishing a maximum nicotine level in cigarettes and certain other combusted tobacco products. FDA is proposing this action to reduce the addictiveness of these products, thus giving people who are addicted and wish to quit the ability to do so more easily. The proposed product standard is anticipated to benefit the population as a whole. For example, it would help to prevent people who experiment with cigarettes and cigars from developing addiction and using combusted tobacco products regularly.

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Compliance, Regulatory 16 Jan 2025 pharmaceuticals, fda, cosmetics, color additives, regulatory compliance, food safety, drugs

🚫FDA Revokes FD&C Red No. 3 for Food and Ingested Drugs

The Food and Drug Administration (FDA or we) is granting a color additive petition submitted by Center for Science in the Public Interest, et al., by repealing the color additive regulations that permit the use of FD&C Red No. 3 in foods (including dietary supplements) and in ingested drugs. The petitioners provided data demonstrating that this additive induces cancer in male rats. Therefore, FDA is revoking the authorized uses in food and ingested drugs of FD&C Red No. 3 in the color additive regulations.

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Regulatory Compliance, Industry Impact 16 Jan 2025 pharmaceuticals, new drug application, fda, drug approval, vanda pharmaceuticals, regulatory compliance

💊FDA Proposes Refusal of TRADIPITANT Drug Application

The Director of the Center for Drug Evaluation and Research (Center Director) at the Food and Drug Administration (FDA or Agency) is proposing to refuse to approve a new drug application (NDA) submitted by Vanda Pharmaceuticals, Inc. (Vanda), for TRADIPITANT capsules, 85 milligrams (mg), in its present form. This notice summarizes the grounds for the Center Director's proposal and offers Vanda an opportunity to request a hearing on the matter.

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Compliance, Regulatory Requirements 16 Jan 2025 malaria, fda, transfusion safety, regulatory compliance, blood industry

🩸FDA Draft Guidance on Reducing Transfusion-Transmitted Malaria Risk

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft document entitled "Recommendations To Reduce the Risk of Transfusion-Transmitted Malaria." The draft guidance document provides blood establishments that collect blood and blood components with FDA's revised recommendations to reduce the risk of transfusion-transmitted malaria (TTM). The guidance recommends selectively testing blood donations from donors at risk for malaria using an FDA-licensed donor screening nucleic acid test (NAT) for Plasmodium species (spp.), the causative agents of malaria. The draft guidance, when finalized, is intended to supersede the document entitled "Recommendations To Reduce the Risk of Transfusion-Transmitted Malaria," dated December 2022.

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Compliance, Regulatory Requirements, Food Safety 15 Jan 2025 agriculture, regulations, fda, food safety, opiate alkaloids, poppy seeds

🥙FDA Seeks Information on Poppy Seed Industry Practices and Safety

The Food and Drug Administration (FDA or we) is requesting information on industry practices related to poppy seeds, such as information about growing, harvesting, processing, and distribution of poppy seeds, including industry practices to reduce the opiate alkaloid content of poppy seeds. We are taking this action, in part, because we have received reports of adverse events related to the use of some poppy seed products. We intend to use the information to help determine what type(s) of actions, if any, we should take to help ensure that poppy seed products do not pose a health risk when consumed.

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Regulatory Compliance, Industry Impact 15 Jan 2025 regulatory compliance, business impact, fda, pharmaceutical, drug approval

💊FDA Withdraws Approval of 12 Drug Applications

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 12 new drug applications (NDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

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Regulatory Compliance, Pharmaceutical Industry 15 Jan 2025 healthcare, fda, pharmaceutical regulation, drug approvals, teva pharmaceuticals

🚫FDA Withdraws Approval of 23 Abbreviated New Drug Applications

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 23 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

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Regulatory Compliance, Financial Opportunities 15 Jan 2025 healthcare, regulatory, fda, pharmaceutical, priority review voucher, rare diseases

💊FDA Issues Priority Review Voucher for Rare Pediatric Disease Product

The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that ALHEMO (concizumab-mtci), approved on December 20, 2024, manufactured by Novo Nordisk, Inc., meets the criteria for a priority review voucher.

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Compliance, Regulatory Requirements 14 Jan 2025 user fee, generic drugs, pharmaceuticals, fda, public comment, regulation, compliance

📄FDA Notice

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with our generic drug user fee program.

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