💊FDA Notice on Type V Drug Master Files for ANDA Support
The Food and Drug Administration (FDA or Agency), Center for Drug Evaluation and Research (CDER), Office of Generic Drugs is establishing a public docket entitled "Use of a Type V Drug Master File (DMF) for Model Master File (MMF) Submissions to Support Abbreviated New Drug Applications (ANDAs)." The purpose of this docket to solicit input from interested parties on this topic.
Learn More📜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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Prevention and Treatment of Chemotherapy-Induced Peripheral Neuropathy: Developing Drug and Biological Products in Oncology."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 Notice on Tobacco Product Establishment Registration Requirements
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 revision of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on "Tobacco Product Establishment Registration and Listing."
Learn More📋FDA Adverse Event Reporting
The Food and Drug Administration (FDA, the Agency, or we) 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 FDA's adverse event reports and product experience reports for FDA-regulated products.
Learn More🚫FDA Withdraws Notice on Treatment Center Program Data Collection
The Food and Drug Administration (FDA) is announcing the withdrawal of a notice that was published in the Federal Register of October 18, 2023.
Learn More📄FDA Extends Comment Period for Accelerated Approval Guidance
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the draft guidance for industry entitled "Expedited Program for Serious Conditions--Accelerated Approval of Drugs and Biologics" that appeared in the Federal Register of December 6, 2024. In the notice of availability for the draft guidance, FDA requested comments on the draft guidance. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
Learn More🏥FDA Workshop on Optimizing Pregnancy Registries
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled "Optimizing Pregnancy Registries." The purpose of the public workshop is to discuss challenges in designing and implementing pregnancy registries and to consider innovative approaches to improve the design and conduct of pregnancy registries to inform the safety of drug and biological products during pregnancy. This public workshop is being held in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation program.
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