SILVER
SPRING, Md., Aug. 2, 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 published the FDA Voices: "Advancing Clinical
Trial Participation for the LGBTQIA+ Community," by Christine Lee, Acting Associate Commissioner for
Minority Health, Office of Minority Health and Health
Equity. Representatives of the FDA were fortunate to
attend a community discussion on advancing clinical trial diversity
for sexual and gender minority communities to help improve the
generalizability of trial results across the entire population of
patients who may use medical products. In collaboration with the
North Carolina Community Health Center Association and the
Association of Clinical Research Professionals-Research Triangle
Park Chapter in North Carolina,
the roundtable included members of the REACH Consortium,
researchers, patients, community members, and LGBTQIA+ health
professionals and advocates.
- On Thursday, the FDA approved Jemperli (dostarlimab-gxly) with
carboplatin and paclitaxel, followed by single-agent
dostarlimab-gxly, for adult patients with primary advanced or
recurrent endometrial cancer (EC). Dostarlimab-gxly previously was
approved with carboplatin and paclitaxel, followed by single-agent
dostarlimab-gxly, for primary advanced or recurrent EC that is
mismatch repair deficient (dMMR) or microsatellite instability-high
(MSI-H).
- On Thursday, the FDA announced the roster of the Digital Health
Advisory Committee that will advise the FDA on issues related to
digital health technologies (DHTs), providing relevant expertise
and perspective to enhance the agency's understanding of the
benefits, risks, and clinical outcomes associated with the use of
DHTs. Additionally, on November 20-21,
2024, the FDA plans to hold the inaugural Digital Health
Advisory Committee meeting in person in Gaithersburg, MD, with simultaneous webcast.
Topics planned to be addressed include how the use of Generative AI
may impact safety and effectiveness of medical devices enabled with
this technology. Further details about this meeting will be
announced in the Federal Register in accordance with the FDA's
policies and procedures for Advisory Committee Meetings.
- On Thursday, the FDA introduced online resources to provide
information about reprocessing single-use medical devices for
health care facilities and FAQs. The FDA remains dedicated to
providing resources to help health care facilities establish,
implement, or improve their quality assurance programs related to
reprocessing single-use medical devices.
- On Thursday, the FDA announced executive career opportunities
related to its reorganization to create a unified Human Foods
Program. The FDA anticipates making more announcements as the
agency continues to work toward the reorganized Human Foods
Program. The reorganization will allow the agency to more
effectively realize the vision laid out in the FDA's Food Safety
Modernization Act, elevate the importance of nutrition to help
reduce diet-related diseases, modernize and strengthen oversight of
food chemical safety, strengthen state partnerships, and embrace
innovative food and agricultural technologies that will position
the agency to more effectively regulate and uphold safety of the
nation's food supply.
"We are pleased to announce these science and policy leadership
openings as an important step in augmenting our expertise to fully
realize the Human Foods Program and further continue our public
health mission" says Jim Jones,
Deputy Commissioner for Human Foods.
- On Wednesday, the FDA issued warning letters to five online
retailers for selling unauthorized disposable e-cigarette products
marketed under the brand names Geek Bar, Lost Mary, and Bang. The
retailers included Smoke and Vape Company, LLC d/b/a Smoke and Vape
Co.; Smoking Vibes LLC d/b/a Smoking Vibes; Cavalry Industries
d/b/a Select Vape; HTXW LLC d/b/a FOMO Culture; and Global Supply
Allies Inc. d/b/a Vapor Grab.
- On Wednesday, the FDA issued a Safety Alert, informing
consumers that after conducting an abbreviated nutrient analysis of
Crecelac Infant Powdered Goat Milk Infant Formula, the agency found
elevated levels of potassium and chloride as well as low levels of
Vitamin A. This product was part of a voluntary recall that the
company initiated on May 24, 2024,
and all caregivers should have already disposed of the product and
discontinued use. If consumers have continued to use this product,
the FDA recommends discontinuing any further use of this
product.
- On Wednesday, the FDA published a Spotlight on CDER Science
describing CDER research that combined the predictive ability of
artificial intelligence/machine learning (AI/ML) with appropriate
validation processes to develop a method to identify a patient
population who will likely benefit from a drug therapy. This was
the first time that CDER used AI/ML for a regulatory decision.
- On Wednesday, the FDA published a summary of the adverse event
reports (AERs) the agency received about Purina pet food between
November 22, 2023, and April 15, 2024. The summary also discusses the
FDA's follow-up activities, including analyzing pet food AERs, pet
owner follow-up interviews, testing opened product samples from pet
owners and sealed product samples from retail settings, and
conducting a facility inspection. The FDA's summary concluded that
there was no direct or consistent connection among the wide range
of AERs submitted to the agency. Additionally, the AERs summary
found that evidence does not identify a public health concern that
could explain the symptoms detailed in the AERs.
- On Wednesday, the FDA issued a Federal Register notice
announcing medical device user fees and annual establishment
registration fees for Fiscal Year 2025 (FY 2025), effective
October 1, 2024, through September 30, 2025. The FDA also announced
updates to the small business fee reductions.
- On Wednesday, the FDA issued a letter to health care providers
to raise awareness, together with Health Canada, about the safe use
of Mega 2000 and Mega Soft Patient Return Electrodes by Megadyne
Medical Products, Inc. Since June
2023, Megadyne has initiated four voluntary recalls due to
reports of burn injuries in pediatric and adult patients and health
care providers. Following the instructions in the manufacturer's
recall notifications can help ensure the safe use of these
products.
- On Wednesday, the FDA announced in the Federal Register the
fiscal year (FY) 2025 fee rates and payment procedures under the
Animal Drug and Animal Generic Drug User Fee Amendments of 2023.
The Animal Drug User Fee Act (ADUFA) authorizes the FDA to collect
user fees for certain animal drug applications and supplemental
applications, products, establishments, and sponsors of animal drug
applications and/or investigational animal drug submissions. These
resources supplement funding provided by Congressional budget
authority to enhance the performance of the review process ensuring
that new animal drug products are safe and effective for animals,
and that food derived from treated animals will be safe for
consumption. The Animal Generic Drug User Fee Act (AGDUFA) was
designed to supplement funding provided by Congressional budget
authority to enhance the performance of the generic new animal drug
review process, which enables the FDA to ensure that generic new
animal drug products are safe and effective.
- On Tuesday, the FDA approved Darzalex Faspro (daratumumab and
hyaluronidase-fihj, Janssen Research & Development, LLC) in
combination with bortezomib, lenalidomide, and dexamethasone for
induction and consolidation in patients with newly diagnosed
multiple myeloma who are eligible for autologous stem cell
transplant (ASCT).
- On Tuesday, the FDA updated the advisory for the Investigation
of Illnesses: Diamond Shruumz-Brand Chocolate Bars, Cones, &
Gummies (June 2024) to include
updated case counts, and a link to a list of store names and
locations where the recalled products were available for retail
sale. This comes after FDA received numerous reports of retailers
continuing to sell the recalled products.
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