SILVER
SPRING, Md., May 3, 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- Today, the FDA announced the availability of draft guidance for
industry (GFI) #290 (VICH GL61) entitled "Pharmaceutical
Development" for veterinary drug products. This draft guidance has
been developed for veterinary use by the International Cooperation
on Harmonisation of Technical Requirements for Registration of
Veterinary Medicinal Products (VICH). VICH is a trilateral program,
officially launched in April 1996,
which aims to harmonize technical requirements for the approval of
veterinary medicinal products in the European Union, Japan, and the
United States, and includes input from both regulatory and
industry representatives. In support of wider international
harmonization of regulatory requirements, VICH guidelines are also
available for use by other countries. The FDA is accepting public
comments on the draft guidance.
- On Thursday, the FDA announced the public meeting, "Evaluating
the Negative Symptoms of Schizophrenia in Clinical Trials," to
discuss approaches to developing drugs to treat the negative
symptoms of schizophrenia and disseminate important regulatory
considerations for programs designed to evaluate these drugs. The
workshop will be August 16, 2024,
both on-site and virtual. Registration is only required for on-site
attendance.
- On Thursday, the FDA published a final rule that revises
certain pre-harvest agricultural water provisions for covered
produce (other than sprouts) in Subpart E of the FDA Food Safety
Modernization Act (FSMA) Produce Safety Rule. Specifically, this
rule replaces the previous pre-harvest water microbial quality
criteria and testing requirements for covered produce (other than
sprouts) with requirements for systems-based, pre-harvest
agricultural water assessments for hazard identification and risk
management decision-making purposes.
- On Thursday, the FDA's Center for Devices and Radiological
Health, Center for Drug Evaluation and Research, and Center for
Biologics Evaluation and Research announced the 2024 Regulatory
Education for Industry (REdI) Annual Conference that will be held
on Wednesday, May 29, 2024, and
Thursday, May 30, 2024. There is no
cost to register and registration is now open.
- On Thursday, the FDA's Office of Translational Sciences (OTS)
within CDER published its 2023 annual report. The report organizes
OTS' achievements by its core activities: drug development and
regulatory review, substance use disorders, inspections, science
and research, knowledge management, and outreach and communications
efforts.
- On Wednesday, the FDA announced the issuance of warning letters
to 14 online retailers for selling unauthorized e-cigarette
products popular among youth. These warning letters cite the sale
of disposable e-cigarette products marketed under popular brand
names such as Elf Bar/EB Design, Esco
Bars, Funky Republic, Hyde, Kang, Cali Bars, and Lost
Mary.
- On Wednesday, the FDA announced the qualification of a new tool
to assess atrial fibrillation burden estimates within clinical
studies through the Medical Device Development Tools (MDDT)
program. The Apple Atrial Fibrillation History Feature is the first
digital health technology qualified under the MDDT program,
providing a non-invasive way to check estimates of atrial
fibrillation (AFib) burden within clinical studies. The device is
designed to be used as a biomarker test to help evaluate estimates
of AFib burden as a secondary effectiveness endpoint within
clinical studies intended to evaluate the safety and effectiveness
of cardiac ablation devices. It is also designed to be used
throughout the clinical study, both before and after cardiac
ablation treatment, to monitor a study participant's weekly
estimate of AFib burden.
- On Wednesday, the FDA announced it was taking important steps
to advance the FDA's regulatory process for intentional genomic
alterations (IGAs) in animals. The agency released updated guidance
documents that underscore the agency's commitment to further
modernize its approach to evaluating and supporting the development
of innovative animal and veterinary products to increase regulatory
flexibility, predictability and efficiency. In addition, the agency
established a memorandum of understanding (MOU) with the U.S.
Department of Agriculture to clarify roles and responsibilities for
regulation of IGAs in animals.
- On Tuesday, the FDA's Center for Drug Evaluation and Research
(CDER) published the 2023 Office of New Drugs (OND) Annual Report,
which captures the office's major achievements of 2023 to include
notable drug approvals, guidances, publications, participation in
meetings, workshops, webinars, conferences, and more. The 2023 OND
Annual Report reflects the wide-ranging efforts of the office in
supporting drug development, conducting extensive application
reviews leading to important drug approvals, advancing policy
through workshops and new guidances, and continuing to assure
careful post-approval drug assessments.
- On Tuesday, the FDA issued an outbreak advisory for a
multistate outbreak of E. coli O157:H7 infections linked to
organic walnuts from Gibson Farms, Inc. of Hollister, California that were distributed to
multiple natural food and co-op stores in AK, AR, AZ, CA, CO, HI,
ID, KS, LA, MT, NE, NM, NV, OR, SD, TX, UT, WA, and WY and sold in
bulk bins. On April 27, 2024, Gibson
Farms, Inc. initiated a voluntary recall and contacted their
distributing customers. Distributors and retailers that may have
received recalled bulk organic walnuts should follow the
recommendations in the advisory and contact their customers. A full
list of store names and locations where recalled walnuts may have
been sold is available. FDA is working with the firm and its
distributors to determine whether additional store locations,
products, or states are affected.
- On Tuesday, as part of its celebration of Asian American,
Native Hawaiian, and Pacific Islander Heritage Month, the FDA
announced the release of the latest episode of the Health Equity
Forum Podcast: "Engaging Native Hawaiian Communities in Clinical
Trials." In this episode, OMHHE Acting Director Dr. Christine Lee speaks with Dr. Todd Seto and Dr. Deb
Taira of the Queen's Medical Center on their research with
the Hawaii Health Equity Research and Outreach Network (Hawaii
HERON). Dr. Seto and Taira's work with Hawaii HERON aims to address
and reduce health disparities experienced by AA and NHPI
communities.
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