📋FDA Guidance on Safety Labeling Changes for Drug Products
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Safety Labeling Changes--Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act." This draft guidance provides information on the implementation of the statutory provision that authorizes FDA to require application holders for certain drug and biological products to make labeling changes based on new safety information that becomes available after approval of the drug that FDA determines should be included in the labeling of the drug. This guidance is being updated and reissued in draft to, among other things, include the addition of information related to Congress' 2018 changes to the definition of adverse drug experience regarding reduced effectiveness and make other changes to reflect current Agency processes and procedures regarding safety labeling changes. This draft guidance revises and, when finalized, will replace the guidance for industry entitled "Safety Labeling Changes--Implementation of Section 505(o)(4) of the FD&C Act" issued in July 2013.
Learn More💊FDA Seeks Comments on Drug Safety Technology Meeting Program
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, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the Emerging Drug Safety Technology Meeting (EDSTM) Program.
Learn More💊FDA Announces Joint Meeting on Opioid Analgesics Regulation
The Food and Drug Administration (FDA) is announcing an amendment to the notice of joint meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. This meeting was announced in the Federal Register of December 9, 2024. The amendment is being made to reflect changes in the DATES, ADDRESSES, and Procedure portions of the document. There are no other changes.
Learn More⚠️National Poison Prevention Week
The proclamation announces National Poison Prevention Week, urging awareness of accidental poisoning, particularly from opioids like fentanyl. It highlights the government's effort to combat drug trafficking and improve community safety through education and preventative measures while establishing a framework for ongoing drug safety initiatives.
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.
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.
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