FDA Roundup: January 05, 2024

SILVER SPRING, Md., Jan. 5, 2024 /PRNewswire/ — Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

• On Wednesday, the FDA issued a safety communication to inform health care providers not to use the Total Hip System, including resurfacing implants, manufactured by Synovo Production, Inc. (Synovo) and to inform patients who may have received certain implants used in the Synovo Total Hip System after 2019 that the safety and effectiveness of these devices have not been established.

• On Wednesday, the FDA issued a Safety Alert warning about certain tejocote root supplements substituted with toxic yellow oleander.

• On January 31 and February 1, the Reagan-Udall Foundation for the FDA, will hold a virtual public workshop, “Advancing Psychedelic Clinical Study Design.” This meeting will bring together researchers, regulated industry, and other key stakeholders to discuss scientific issues that arise while working with psychedelics in clinical trials and drug development. In June 2023, the FDA issued its first draft psychedelics guidance for industry, Psychedelic Drugs: Considerations for Clinical Investigations, to provide general considerations to sponsors developing psychedelic drugs for treatment of medical conditions (e.g., psychiatric disorders, substance use disorders).

  The goals of the meeting include:

  • Understanding the experiences of scientists working with psychedelics in FDA-authorized clinical studies and drug development;

  • Exploring considerations for psychedelic clinical trial designs; and

  • Exploring perspectives and current research in psychedelic clinical trials.

Additional Resources:

Media Contact: FDA Office of Media Affairs, 301-796-4540
Consumer Inquiries: 888-INFO-FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.

 

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SOURCE U.S. Food and Drug Administration