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
MedicalDeviceSterilization@fda.hhs.gov.
- 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:
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