SILVER
SPRING, Md., June 25,
2024 /PRNewswire/ -- Today, the U.S. Food and Drug
Administration is providing an at-a-glance summary of news from
around the agency:
- On Monday, the FDA issued a Small Entity Compliance Guide to
assist small entities in complying with the FDA's regulations as
they apply to in vitro diagnostic (IVD) products, including
laboratory developed tests (LDTs). The LDT Final Rule published on
May 6, 2024, amends the FDA's
regulations to make explicit that IVDs 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 LDT Final Rule includes a policy under which FDA will phase out
its general enforcement discretion approach for LDTs over the
course of four years so that IVDs manufactured by a laboratory will
generally fall under the same enforcement approach as other IVDs.
The phaseout includes targeted enforcement discretion policies for
specific categories of IVDs manufactured by laboratories.
- On Friday, the FDA issued a new report, New Drugs Regulatory
Program Modernization – Impact Narrative Update 2023. In
2017, CDER began an initiative to modernize its New Drugs
Regulatory Program (NDRP), to continuously improve regulatory
science and review. This report provides a detailed look at the
strategic objectives and impact of NDRP modernization progress, as
well as on continued efforts toward reaching program goals. For
more information about NDRP modernization efforts, please see this
CDER Conversation with Yoni Tyberg, associate director of the
Special Program Staff in the Office of New Drugs.
- On Friday, the FDA converted Sirturo (bedaquiline) to
traditional approval following a determination that a confirmatory
trial verified clinical benefit. Sirturo is indicated for pulmonary
tuberculosis (TB) due to Mycobacterium tuberculosis
resistant to at least rifampin and isoniazid, also known as
multi-drug resistant tuberculosis (MDR-TB), as part of a
combination therapy, for adults and pediatric patients (5 years and
older, weighing at least 15 kg). Sirturo was first approved in
December 2012 under the FDA's
Accelerated Approval pathway. As part of the initial approval, the
FDA required the applicant to conduct a confirmatory clinical study
and develop a patient registry to assess rates of serious adverse
events.
- On Friday, the FDA granted accelerated approval to Krazati
(adagrasib) plus cetuximab for adults with KRAS G12C-mutated
locally advanced or metastatic colorectal cancer (CRC), as
determined by an FDA-approved test, who have received prior
treatment with fluoropyrimidine-, oxaliplatin-, and
irinotecan-based chemotherapy. The most common adverse reactions
(≥20%) were rash, nausea, diarrhea, vomiting, fatigue,
musculoskeletal pain, hepatotoxicity, headache, dry skin, abdominal
pain, decreased appetite, edema, anemia, cough, dizziness,
constipation, and peripheral neuropathy. Full prescribing
information for Krazati will be posted on Drugs@FDA.
- On Friday, the FDA approved Vyvgart Hytrulo (efgartigimod alfa
and hyaluronidase-qvfc) for the treatment of chronic inflammatory
demyelinating polyneuropathy (CIDP) in adults. CIDP is a rare type
of immune-mediated, inflammatory, peripheral nerve disorder that
affects the myelin sheaths - the fatty coverings on the fibers that
insulate and protect the nerves. Symptoms of CIDP include
progressive weakening of the arms and legs, numbness and tingling,
impaired balance, and difficulty walking.
Vyvgart Hytrulo was previously approved for the treatment of adults
with generalized myasthenia gravis (gMG) who are anti-acetylcholine
receptor (AChR) antibody positive. The most common adverse
reactions (≥ 10%) of patients with gMG treated with Vyvgart were
respiratory tract infections, headache, and urinary tract
infection. Injection site reactions were also present (≥ 15%) in
patients with CIDP who were treated with Vyvgart Hytrulo.
- On Thursday, the FDA posted a grant opportunity to develop
cooperative agreement(s) with academic research institutions to
establish Animal and Veterinary Innovation Centers. This effort is
part of the FDA's ongoing commitment to encourage development of
innovative products to better support animal health and veterinary
interventions, including those that prevent, control, or eliminate
Highly Pathogenic Avian Influenza virus in animals, or
interventions that reduce the circulation of the virus in the
ecosystem.
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