SILVER
SPRING, Md., July 16,
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 revised final guidance Application
User Fees for Combination Products. Combination products may be
reviewed in a single application or in separate applications for
the constituent parts, as appropriate. This guidance explains that
combination products for which a single application is submitted
should be assessed the applicable user fee associated with that
particular type of application. When separate applications are
submitted for the constituent parts of a combination product, the
document explains how the Agency applies user fees. It also
includes revisions for consistency with current medical device and
drug user fee programs and legislation. This guidance replaces the
final guidance of the same title issued in 2005.
- On Monday, the FDA authorized marketing of DiaSorin Molecular
LLC's Simplexa C. auris Direct, a molecular-based assay intended to
detect Candida auris (C. auris) DNA from a skin swab
of the armpit or groin from patients suspected of C. auris
colonization. The test is intended to help prevent and control
C. auris infections in health care settings. The assay may
allow health care professionals to evaluate patients for
colonization with C. auris faster than traditional
culture-based techniques when such testing is needed. Faster
detection can help stop the spread of this organism, which is
frequently resistant to multiple antifungal drugs and can cause
serious infections in hospitalized patients. Test results are meant
to be used in conjunction with other clinical, epidemiologic, and
laboratory information available to the clinician evaluating the
patient. The test is not intended to diagnose or monitor treatment
for C. auris infection. This is the latest example of the FDA's
ongoing commitment to helping ensure the development and expansion
of tests for emerging infectious pathogens.
- On Monday, the FDA announced organizational changes within the
Center for Devices and Radiological Health (CDRH) to help
strengthen and better position the Center to meet FDA's mission to
protect and promote the public health. CDRH elevated the Office of
Communication and Education into a Super Office that will be
responsible for delivering clear, meaningful, insights-based
communications, education, and disclosures about medical devices
and radiation-emitting products. In addition, CDRH is making
structural changes within the Office of Product Evaluation and
Quality in both the Office of Clinical Evidence and Analysis and
the Office of Health Technology 4: Surgical and Infection Control
Devices to help improve efficiencies within the offices and better
meet the needs of FDA's customers. This new reorganization across
offices will increase organizational agility and advance the FDA's
efforts to meet commitments under the Medical Device User Fee
Amendments (MDUFA) V reauthorization, as well as the 2022-2025
Strategic Priorities.
- On Monday, the FDA issued a guidance, Drugs for the Treatment
of Partial Onset Seizures: Extrapolation of Efficacy from Adults to
Pediatric Patients 1 Month of Age and Older. This guidance provides
recommendations to sponsors on the clinical development of drugs to
treat partial onset seizures (POS) in pediatric patients. It
addresses FDA's current thinking regarding clinical development
programs that can support using data approved for the treatment of
POS in adults to support treatment options for pediatric patients 1
month of age and older. Previous clinical studies of drugs for the
treatment of POS in pediatric patients as young as 1 month have
showed a reduction in seizure frequency similar to the response to
treatment seen in adults. These historical studies showing similar
performance of drugs to treat POS in children and adults further
support the use of adult data to show effectiveness from adults to
pediatric patients. The revised guidance replaces a guidance, Drugs
for the Treatment of Partial Onset Seizures: Full Extrapolation of
Efficacy from Adults to Pediatric Patients 2 Years of Age and
Older.
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