SILVER
SPRING, Md., Aug. 9, 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 invites the public to register for the public
meeting on the Development of an Enhanced Systematic Process for
the FDA's Post-Market Assessment of Chemicals in Food, which will
be held on September 25, 2024, from
12:30-4:30 p.m. ET. The purpose of
this meeting is for FDA to share information about the development
of FDA's enhanced systematic process for post-market assessment of
chemicals in food, including considerations for identifying and
prioritizing food chemicals currently in the market for safety
reviews. In addition, industry and consumer advocacy experts,
government officials, research organizations, and other
stakeholders will have the opportunity to learn more, ask
questions, and provide open public comment to address specific
questions posed by the FDA. This information will help inform our
further development of the process. This project is part of a
larger enhanced approach for food chemical safety. For additional
information about the meeting, including how to request to make
open public comments, please visit the Federal Register Notice.
- On Thursday, the FDA released a set of documents regarding the
transition phase after the agency's longstanding Memorandum of
Understanding with the Association of American Feed Control
Officials (AAFCO) expires on October 1,
2024. The documents include a request for public comments on
the FDA's existing pre-market animal food ingredient review
programs, Draft Guidance for Industry #293, FDA Enforcement Policy
for AAFCO-Defined Animal Feed Ingredients, and Draft Guidance for
Industry #294, Animal Food Ingredient Consultation (AFIC). The FDA
is accepting public comments on the two draft guidances until
September 9, 2024, and on the request
for comments until December 9,
2024.
- On Thursday, the FDA released its updated 2024 Language Access
Plan, taking another key step toward addressing language barriers
that impact health equity and strengthening language access to
health information and services for the public, including people
with Limited English Proficiency and people with disabilities. The
plan also supports FDA efforts to identify interpretation language
assistance, translate, and make important documents accessible, as
well as digital and web content into multiple languages. The
Language Access Program, led by the FDA's Office of Minority Health
and Health Equity, is a part of the FDA's ongoing work to help
individuals make informed decisions about their health.
- On Thursday, the FDA granted an emergency use authorization to
Octapharma Pharmazeutika Produktionsges.m.b.H. for emergency use of
octaplasLG Powder (blood group types A and AB) for U.S. military
forces for the treatment of hemorrhage or coagulopathy during an
emergency involving agents of military combat (e.g., firearms,
projectiles, and explosive devices) when plasma is not available
for use or when the use of plasma is not practical.
Hemorrhage, sometimes accompanied by coagulopathy (a condition that
affects the blood's ability to clot), is a leading cause of death
among combat trauma casualties. Plasma contains proteins that may
be effective at helping clot blood and can be used for the
management of hemorrhage and coagulopathy. However, its use in
combat settings is severely limited by logistical and operational
challenges such as the need for refrigeration and, in the case of
frozen plasma, a long thawing period.
OctaPlasLG Powder is a powdered freeze-dried product that can be
used following reconstitution (adding water back to the powder) in
settings where refrigeration is not available, thus enabling the
rapid availability of plasma for use at the point of injury.
Information is available on FDA's website.
- On Wednesday, the FDA updated the list of Artificial
Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices.
With this update, the FDA has authorized 950 AI/ML-enabled medical
devices. The devices in this list have met the FDA's applicable
premarket requirements, including a focused review of the devices'
overall safety and effectiveness, which includes an evaluation of
appropriate study diversity based on the device's intended use and
technological characteristics.
- On Tuesday, the FDA published a blog titled FDA India Office
Addresses Herbal and Ayurvedic Products. This latest in the FDA's
"From A Global Perspective" series and discusses the FDA's take on
the regulatory issues surrounding India's Ayurvedic and Herbal exports, many of
which are based on centuries-old traditional medicine.
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