💊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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