FDA Roundup: April 16, 2024

SILVER SPRING, Md., April 16, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

• Today, the FDA's Center for Devices and Radiological Health (CDRH) announced the unveiling of a new public dataset designed to help assist chemistry labs in ensuring the robustness of chemical characterization methods used to assess the biocompatibility of medical devices. This dataset of chemicals allows analytical chemistry labs to determine their ability to detect a broad range of potential chemicals. This new dataset is part of CDRH's ongoing commitment to reduce the burden of premarket processes, while increasing the consistency and transparency of biocompatibility methods.
  
  
• On Monday, the FDA announced the next Medical Device Sterilization Town Hall: Topics and Formats for the Continuing Sterilization Series that will be held on Monday, April 29, 2024, 1- 2 p.m. ET. During this town hall, the FDA will discuss suggestions received on potential topics for the sterilization town hall series and how the FDA will pivot the format of the series to support more engaging discussions on topics of interest. Registration is not required to attend. Attendees may submit questions at least one week in advance to [email protected].
  
  
• On Monday the FDA published the FDA Voices: "Reflections on Travel to Europe – Part One," by Robert M. Califf, M.D., Commissioner of Food and Drugs. In this part one of a three-part series of blogs, Dr. Califf provides his perspective on his recent trip to Europe and describes key events and issues. The team's official travel took them to the U.K. and the European Union (EU) and included visits with The Medicines and Healthcare products Regulatory Agency, representatives of the U.K. medical device, digital and pharmaceutical industries in London and a visit to Oxford for an exchange and update on the conduct of clinical trials and mutual concerns about cybersecurity. Dr. Califf and the FDA team also traveled to Brussels for visits with the U.S. Mission to the EU; the European Commission; the European Food Safety Authority; representatives of European medical products and food industries; and the European Medicines Agency.
  
  
• On Monday, the FDA announced the launch of the CDER Center for Clinical Trial Innovation (C3TI). C3TI's mission is to promote CDER clinical trial innovation activities through enhanced communication and collaboration, both internally within CDER and externally. C3TI will be a central hub within CDER that supports innovative approaches to clinical trials that are designed to improve the efficiency of drug development. This new center within CDER will enable both internal and external parties to access information on clinical trial innovation efforts more easily, engage in collaborations, identify resources that can further support the use of innovative modalities, and identify development programs where a concerted approach to the use of clinical trial innovations would be impactful. For more information about C3TI, including how to participate in a project in the C3TI Demonstration Program, explore the C3TI webpage. Visit the CDER Conversation with Dr. Kevin Bugin, deputy director for operations in CDER's Office of New Drugs and lead for C3TI to learn more about the impetus for establishing C3TI and the center's forward-facing goals and objectives.
  
  
• On Friday, the FDA posted a new video in the "FDA In Your Day" series. In this video, Principal Deputy Commissioner Dr. Namandjé Bumpus discusses allergy medicine and food safety.

 Additional Resources: 

• FDA Newsroom  

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.

SOURCE U.S. Food and Drug Administration