SILVER
SPRING, Md., July 12,
2024 /PRNewswire/ -- Today, the U.S. Food and Drug
Administration is providing an at-a-glance summary of news from
around the agency:
- On Wednesday, the FDA issued a Letter to Health Care Providers
to notify providers that we are aware the U.S. is experiencing
interruptions in the supply of BD BACTEC blood culture media
bottles because of recent supplier issues. The FDA also updated the
medical device shortage list to include blood culture media bottles
(product code MDB). The disruption in availability of this device
is expected to have impact on patient diagnosis, follow up patient
management, and antimicrobial stewardship efforts. The FDA
recommends laboratories and health care providers consider
strategies to conserve the use of blood culture media bottles for
patients at highest risk.
- On Wednesday, the FDA announced a webinar: In Vitro Diagnostic
Products (IVDs) - MDR Requirements, Correction and Removal
Reporting Requirements, and Quality System Complaint Requirements
that will be held on Thursday, Aug. 22,
2024, from 1-2:30 p.m. ET. The
webinar will provide information on how to comply with medical
device reporting requirements, correction and removal reporting
requirements, and quality system requirements regarding complaint
files. The FDA will expect compliance with these requirements for
IVD offered as laboratory developed tests beginning May 6, 2025. This is Stage 1 of the phaseout
policy in the final rule amending the FDA's regulations to make
explicit that IVD products are devices under the Federal Food,
Drug, and Cosmetic Act including when the manufacturer of the IVD
is a laboratory. Along with this amendment, the FDA outlined a
policy to phase out, over the course of four years, its general
enforcement discretion approach to laboratory developed tests.
- On Wednesday, the FDA issued this final guidance: Clinical
Considerations for Studies of Devices Intended to Treat Opioid Use
Disorder. This final guidance provides recommendations for the
design of pivotal clinical studies for devices intended to treat
opioid use disorder (OUD) and used to support marketing
submissions. OUD device studies designed using the recommendations
identified in this guidance may advance the treatment of OUD by
providing scientific evidence that aids the FDA in determining
whether there is a reasonable assurance that a device intended to
treat OUD is safe and effective. The opioid overdose crisis is a
serious and complex challenge facing the U.S. The FDA has taken
significant steps to decrease public exposure to opioids, prevent
new cases of OUD, and support the treatment of those with OUD.
- On Tuesday, the FDA announced the approval of Felanorm, the
first generic methimazole oral solution for the treatment of
hyperthyroidism in cats. Felanorm contains the same active
ingredient (methimazole) as the approved brand name drug product,
Felimazole Coated Tablets, which were first approved on
May 27, 2009. Felanorm is only
available by prescription from a licensed veterinarian because
professional veterinary expertise is needed to diagnose
hyperthyroidism in cats and to determine whether Felanorm is an
appropriate treatment. Continued veterinary monitoring is also
needed to ensure that the dose continues to be appropriate to
control the cat's hyperthyroidism, as this disease can progress
over time. Felanorm is sponsored by Norbrook Laboratories Ltd.
based in the United Kingdom.
- On Tuesday, the FDA updated the advisory for the investigation
of illnesses linked to Diamond Shruumz-brand products to report
additional cases. Retailers should not sell or distribute any
flavor of Diamond Shruumz-brand Chocolate Bars, Cones, or Gummies,
and should hold the product in a secure location and contact the
recalling company to initiate the return and refund.
- On Tuesday, the FDA updated the advisory for illnesses linked
to bulk organic walnuts. The FDA and CDC, in collaboration with
state and local partners, investigated illnesses in 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, AZ, CA, CO, HI, ID,
MT, NM, OR, SD, TX, and WA and sold in bulk bins. As of
July 9, 2024, CDC reports that the
outbreak is over. The FDA's outbreak investigation is closed.
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