SILVER
SPRING, Md., July 23,
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 approved Femlyv (norethindrone acetate
and ethinyl estradiol), the first orally disintegrating tablet
approved for the prevention of pregnancy. Norethindrone acetate and
ethinyl estradiol, the main ingredients in Femlyv, have been
approved in the U.S. for the prevention of pregnancy as a
swallowable tablet since 1968.
"Femlyv is the first FDA approved dissolvable birth control pill,
designed for individuals who have trouble swallowing their
medication," said Janet Maynard,
M.D., M.H.S., director of the Office of Rare Diseases, Pediatrics,
Urologic and Reproductive Medicine in the FDA's Center for Drug
Evaluation and Research. "There are many variables that might cause
someone to have difficulty swallowing. This drug provides another
treatment option and expands access to this form of contraception
for individuals who may have experienced those challenges."
The most common adverse reactions to Femlyv are headache,
vaginal candidiasis, nausea, menstrual cramps, breast tenderness,
bacterial vaginitis, abnormal cervical smear, acne, mood swings,
and weight gain. See full prescribing information for additional
information on the safety and effectiveness of Femlyv.
- On Monday, the FDA published common questions received
related to laboratory developed tests (LDTs). To ensure
transparency, the FDA intends to respond to generally applicable
questions, as appropriate, in a public manner, such as in webinars,
guidances, FAQ page, and other resources over the course of the
phaseout period for the general enforcement discretion to help
assure the safety and effectiveness of in vitro diagnostic products
offered as LDTs. The FDA intends to update the FAQ page
periodically. For assistance with questions not answered on the FAQ
page, please contact the FDA through the mailbox at
ldtfinalrule@fda.hhs.gov.
- On Monday, the FDA announced an update to the Influenza
Diagnostic Tests web page, indicating that LDTs for Highly
Pathogenic Avian Influenza (HPAI) offered by clinical laboratories
that are certified under Clinical Laboratory Improvement Amendments
(CLIA) and qualified to perform high-complexity testing currently
fall under the FDA's general enforcement discretion approach for
LDTs. The FDA generally does not expect clinical laboratories that
are certified under CLIA and qualified to perform high-complexity
testing to request marketing authorization from the FDA for their
LDTs for HPAI prior to them offering those LDTs. The FDA would not
issue Emergency Use Authorizations for such in vitro diagnostics
given that there is no relevant section 564 declaration.
- On Thursday, July 18, the
FDA announced an update about the ongoing evaluation of
quality and performance issues related to plastic syringes made in
China. Specifically, the FDA
announced the issuance of an additional warning letter to Jiangsu
Shenli Medical Production Co., Ltd. for quality system violations
for syringe products. As a result, the company's entry on import
alert 89-04 was expanded to prevent their enteral syringes from
entering the U.S. A warning letter was also issued to Jiangsu Caina
Medical Co. Ltd. for quality system violations. The FDA
recommendations have been updated to include that users should also
immediately transition away from using enteral syringes
manufactured by Jiangsu Shenli Medical Production Co. Ltd., unless
use of these syringes is absolutely necessary until the transition
to enteral syringes manufactured by a different manufacturer can be
completed.
- On Thursday, July 18, the FDA
announced a public workshop titled Accreditation Scheme for
Conformity Assessment (ASCA) and Use of Chemical Analysis to
Support Biocompatibility of Medical Devices that will be held
on Wednesday, November 6, 2024. The
purpose of this public workshop is to discuss the possible
expansion of the ASCA Program to include chemical analysis to
support biocompatibility of medical devices. The workshop will be
at the FDA's White Oak campus in
Silver Spring, Md., and webcast.
Those attending by webcast will be in listen-only mode. The
registration deadline is Wednesday, October
30, 2024. Please submit comments to Docket FDA-2024-N-3336
by December 6, 2024.
- On Thursday, July 18, the FDA
published the FDA Voices "Catching Up with Califf: Men's
Health is Falling Behind – Some Thoughts About Why," by
Robert M. Califf, M.D., Commissioner
of Food and Drugs. In this part two of a series on men's health,
Dr. Califf further examines the potential underlying reasons for
the decline in men's health.
- On Thursday, July 18,
the FDA authorized the marketing of seven e-cigarette products
in the United States through the
premarket tobacco product application pathway. Following an
extensive scientific review, the FDA issued marketing granted
orders to R.J. Reynolds Vapor Company for the Vuse Alto Power Unit
and six Vuse Alto tobacco-flavored pods, which are sealed,
pre-filled, and non-refillable:
- Vuse Alto Pod Golden Tobacco 5%
- Vuse Alto Pod Rich Tobacco 5%
- Vuse Alto Pod Golden Tobacco 2.4%
- Vuse Alto Pod Rich Tobacco 2.4%
- Vuse Alto Pod Golden Tobacco 1.8%
- Vuse Alto Pod Rich Tobacco 1.8%
While the FDA is authorizing the marketing of
these tobacco products in the U.S., it does not mean these tobacco
products are safe nor are they "FDA approved."
- On Wednesday, July 17, the FDA
published the FDA Voices: "FDA Rare Disease Innovation Hub to
Enhance and Advance Outcomes for Patients," by Patrizia Cavazzoni, M.D., director of the Center
for Drug Evaluation and Research and Peter
Marks, M.D., Ph.D., director of the Center for Biologics
Evaluation and Research. The FDA plans to establish a Rare Disease
Innovation Hub (the Hub). The Hub will work across rare diseases
but will especially focus on products intended for smaller
populations or for diseases where the natural history is variable
and not fully understood.
- On Tuesday, July 16, the FDA
published the FDA Voices: "From Awareness to Action: Tackling the
Rising Burden of Common Chronic Diseases," by Robert M. Califf, M.D., Commissioner of Food and
Drugs. In this FDA Voices, Dr. Califf expounds on the recent
decline in life expectancy in the U.S. largely due, in part, to the
cumulative impact of common chronic diseases. Chronic diseases of
the heart, lungs, kidneys, liver, and metabolism (such as obesity
and diabetes) account for the vast majority of deaths in this
country.
- On Tuesday, July 16, the FDA
issued a draft guidance for industry, "Pediatric Inflammatory Bowel
Disease: Developing Drugs for Treatment," to help sponsors in the
clinical development of drugs to treat pediatric patients with
inflammatory bowel disease (IBD). Specifically, this guidance
provides the agency's recommendations about the necessary
attributes of clinical studies for drugs being developed for the
treatment of pediatric ulcerative colitis or pediatric Crohn's
disease, including study design, study population, efficacy
considerations and safety assessments. This is the agency's first
guidance focused on clinical studies for drugs for the treatment of
pediatric IBD. When finalized, this guidance will represent the
FDA's current thinking on this topic.
- On Thursday, July 25, from
12-4 p.m. ET, the FDA will host a
virtual public meeting to discuss the Home as a Health Care Hub
initiative. During this meeting, the FDA will review the Home as a
Health Care Initiative, seek input from the public, and start a
dialogue about barriers and opportunities associated with making
the home part of the health care system. Participants should
register by July 25, at 11 a.m. ET.
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