SILVER
SPRING, Md., May 21, 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 announced that registration is open for the
two-day virtual public meeting, "FDA's Fifth Online Controlled
Substances Summit." The goal of this summit, hosted in
partnership with the Reagan-Udall Foundation for the FDA, is to
identify innovative solutions to reduce the illegal availability of
controlled substances online. Day one of the summit will be a
public session with FDA leadership, including Commissioner
Robert Califf, and other experts
that will examine the impact and evolution of online purchases of
controlled substances, as well as review progress that has been
made since last year's summit. Day two is an invitation-only
working session that will engage social media, internet, technology
and controlled substances experts in intensive planning and
evaluation to identify immediately implementable actions as well as
long-term strategies that aim to disrupt the trajectory of the
current crisis.
- Today, the FDA announced it is extending the comment period for
the proposed rule entitled "Labeling Requirements for Approved or
Conditionally Approved New Animal Drugs" by 60 days. The agency is
taking this action in response to a request for an extension to
allow interested persons additional time to submit comments. Either
electronic or written comments must be submitted by August 9, 2024.
- On Monday, the FDA approved the first two interchangeable
biosimilars to Eylea (aflibercept), Yesafili (aflibercept-jbvf) and
Opuviz (aflibercecpt-yszy). Aflibercept products work by inhibiting
vascular endothelial growth factors (VEGF) and preventing new or
abnormal blood vessel growth within the eye. By blocking VEGF,
these products can help to slow down or reduce damage to the retina
and preserve vision. Additional information about these
medications, including their risks and side effects, can be found
at the CDER notable approval webpage.
- On Monday, the FDA published the FDA Voices: "FDA Promotes
Clinical Trial Innovation," by Hilary
Marston, MD, MPH, Chief Medical Officer and Kevin Bugin, PhD, Deputy Director of Operations
in the Office of New Drugs, Center for Drug Evaluation and
Research. As the FDA observed Clinical Trials Day yesterday, we
reflected on the progress made and the widespread efforts underway
to advance clinical trial innovation. This progress has been
possible because of clinical trial participants and their families,
health care professionals, medical product developers, federal
partners and the entire clinical research community.
- On Monday, the FDA announced a public workshop, Evaluating
Immunosuppressive Effects of In Utero Exposure to Drug and Biologic
Products. The purpose of the workshop is to discuss transplacental
transfer of drug and biological products with immunosuppressive
properties and the potential clinical impact on the developing
fetus and newborn infant, understand the gaps in knowledge, and
consider innovative approaches to improve collection of relevant
data. The workshop will be held July
11 and 12 on-site at FDA's White Oak Campus (Silver Spring, MD) and virtually. Registration
is required for both online and on-site attendance.
- On Monday, the FDA Oncology Center of Excellence (OCE)
announced the formation of The OCE Equity Program. The new program
expands Project Equity, continuing the OCE's work to improve access
to clinical trials of oncology medical products for populations
that have been historically underrepresented in clinical research.
The OCE formed Project Equity in 2021 to focus the OCE's
longstanding efforts to address the well-documented
underrepresentation of racial and ethnic subgroups in clinical
trials. In addition to racial and ethnic minorities, the OCE Equity
Program will continue the OCE's efforts to improve trial access for
individuals who live in rural areas, sexual and gender minorities,
and individuals with economic, linguistic, or cultural barriers to
healthcare services.
- On Monday, the FDA announced the launch of the Center for
Devices and Radiological Health and Office of Digital
Transformation's precisionFDA Phase 1 of the Digitally-Derived
Endpoints for Freezing-of-Gait Detection Challenge on May 28, 2024. The Challenge seeks artificial
intelligence (AI) models to identify and predict digitally-derived
endpoints for freezing of gait events related to Parkinson's
disease. Medical device developers, tech innovators, software
developers, and academic researchers are invited to participate.
Register to participate in the challenge today and submit AI models
before August 2, 2024.
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