📜FDA's New Compliance Requirements for Adverse Event Reporting
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Learn More❌FDA Withdraws Direct Final Rule on Regulatory Hearing Provisions
The Food and Drug Administration (FDA or Agency) published in the Federal Register of September 20, 2024, a direct final rule amending the Scope section of our regulation that provides for a regulatory hearing before the Agency. The comment period closed December 4, 2024. FDA is withdrawing the direct final rule because the Agency received significant adverse comment.
Learn More🧬FDA Workshop on Cell Therapies
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following virtual public workshop entitled "Cell Therapies and Tissue-Based Products: A Public Workshop on Generating Scientific Evidence to Facilitate Development." The purpose of this workshop is to discuss the current state of the science for development and testing of certain cellular therapies and tissue-based products. In particular, FDA is convening this public workshop with relevant stakeholders to discuss best practices on generating scientific data necessary to further facilitate the development of cellular therapies, including stem cell products.
Learn More💊FDA Guidance on Chemotherapy-Induced Peripheral Neuropathy Available
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Prevention and Treatment of Chemotherapy-Induced Peripheral Neuropathy: Developing Drug and Biological Products in Oncology." Chemotherapy-induced peripheral neuropathy (CIPN), a painful, disabling, and potentially irreversible condition commonly affecting patients receiving neurotoxic chemotherapies, could diminish survival by potentially increasing chemotherapy treatment interruptions, dose reductions, and discontinuations. This guidance provides recommendations to sponsors for the clinical development of drug and biological products intended for the prevention and treatment of CIPN in oncology patient populations.
Learn More🚫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.
Learn More🚬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.
Learn More💊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.
Learn More🐾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.
Learn More🩸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.
Learn More🥙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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