SILVER
SPRING, Md., June 18,
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 a request for input about patient
safety associated with certain medical software functions excluded
from the medical device definition. This input will help the FDA
develop the 2024 report on the risks and benefits to health of
non-device software functions. Please submit comments under docket
number FDA-2018-N-1910 at www.regulations.gov by July 18, 2024.
- The FDA recently issued a warning letter to Dollar Tree Inc.,
as an additional step following the investigation of lead and
chromium in apple cinnamon fruit puree pouches this past fall that
was prompted by findings of elevated blood lead levels in children.
The FDA issued the warning letter to Dollar Tree Inc., because, at
the time of the recall, the company failed to adequately remove
recalled WanaBana apple cinnamon fruit puree pouches from its store
shelves. The FDA has asked the company to respond within 15 days of
receipt of the warning letter stating the specific steps it has
taken to address any violations and prevent the recurrence of
violations or providing its reasoning and supporting information as
to why the company believes it is not in violation of the law.
- On Monday, FDA approved the vaccine, Capvaxive, for the
following indications and use:
- for the prevention of invasive disease caused by 22 different
serotypes of Streptococcus pneumoniae covered by the vaccine for
individuals 18 years of age and older.
- for the prevention of pneumonia caused by 21 different
serotypes of Streptococcus pneumoniae covered by the vaccine for
individuals 18 years of age and older.
Streptococcus pneumoniae, also known as
pneumococcus, are bacteria that can infect the lungs causing
pneumonia, but when they infect the blood (bacteremia) or the
coverings of the brain or spinal cord (meningitis) it is called
invasive pneumococcal disease. It can be a very serious disease.
The vaccine is manufactured by Merck Sharp & Dohme LLC.
- On Monday, the FDA announced the first of a series of five
public meetings to provide educational sessions for stakeholders
who are interested in the new animal drug approval process. The
annual educational conferences the FDA will host over the next four
years are described in the "Animal Drug User Fee Act
Reauthorization Performance Goals and Procedures Fiscal Years 2024
Through 2028." The first educational conference will be held on
July 17, 2024, from 9 a.m. to 5 p.m. ET. Attendees can join in-person
or virtually.
- On Monday, the FDA's Center for Devices and Radiological Health
published a new blog: The Promise Artificial Intelligence Holds
for Improving Health Care. Artificial intelligence (AI)
is rapidly changing the health care industry and holds
transformative potential. Among the possibilities AI offers are
significantly improving patient care and medical professional
satisfaction, accelerating and advancing research in medical device
development and drug discovery, and driving operational efficiency
by enabling personalized treatment and streamlining health care
processes. At the FDA, we know that the proper integration of AI
across the health care ecosystem will be important to achieving its
potential while reducing risks and challenges.
- On Monday, the American Society of Addiction Medicine issued
the draft "Clinical Practice Guideline on Benzodiazepine Tapering,"
which is now available for public comment. The development of this
guideline was funded by an FDA-provided grant and in partnership
with the American Academy of Family Physicians, the American
Academy of Neurology, the American Academy of Physician Associates,
the American Association of Medical Toxicology, the American
Association of Nurse Practitioners, the American Association of
Psychiatric Pharmacists, the American College of Obstetricians and
Gynecologists, the American Geriatrics Society, and the American
Psychiatric Association.
- On Monday, the FDA approved pembrolizumab (Keytruda, Merck)
with carboplatin and paclitaxel, followed by single-agent
pembrolizumab, for adult patients with primary advanced or
recurrent endometrial carcinoma. Adverse reactions associated with
pembrolizumab and chemotherapy were generally similar to those
previously reported for pembrolizumab or chemotherapy with the
exception of a higher incidence of rash. See the prescribing
information for complete adverse reactions. Full prescribing
information for Keytruda will be posted on Drugs@FDA.
- On Friday, the FDA issued a Proposed Administrative Order:
Amending Over-the-Counter Monograph M013: Internal Analgesic,
Antipyretic, and Antirheumatic Drug Products for Over-the-Counter
Human Use. The agency is issuing this FDA-initiated proposed
administrative order (proposed order), to address a safety issue
related to over-the-counter monograph drug products containing
acetaminophen. This proposed order, if finalized, would require
drug companies to add a warning to the labeling. Additional
information can be found in the CDER Statement about this proposed
order.
- On Friday, the FDA published a summary of the patient listening
sessions held in March 2024 on
Attention-Deficit/Hyperactivity Disorder (ADHD). The goal of the
sessions is to help FDA's staff better understand patient
perspectives about their diagnosis and the risks and benefits
associated with stimulant and non-stimulant treatment for ADHD.
- On Friday, the FDA approved durvalumab (Imfinzi, AstraZeneca UK
Limited) with carboplatin plus paclitaxel followed by single-agent
durvalumab for adult patients with primary advanced or recurrent
endometrial cancer that is mismatch repair deficient (dMMR). The
most common adverse reactions (>25%) with durvalumab in
combination with carboplatin and paclitaxel were peripheral
neuropathy, musculoskeletal pain, nausea, alopecia, fatigue,
abdominal pain, constipation, rash, diarrhea, vomiting, and cough.
Full prescribing information for Imfinzi will be posted on
Drugs@FDA.
- On Friday, the FDA approved blinatumomab (Blincyto, Amgen Inc.)
for adult and pediatric patients one month and older with
CD19-positive Philadelphia
chromosome-negative B-cell precursor acute lymphoblastic leukemia
(Ph-negative BCP ALL) in the consolidation phase of multiphase
chemotherapy. In Study E1910, the most common adverse reactions
(≥20%) in the blinatumomab arm were neutropenia, thrombocytopenia,
anemia, leukopenia, headache, infection, nausea, lymphopenia,
diarrhea, musculoskeletal pain, and tremor. In Study 20120215, the
most common adverse reactions (≥20%) in the blinatumomab arm were
pyrexia, nausea, headache, rash, hypogammaglobulinemia, and anemia.
Full prescribing information for Blincyto will be posted on
Drugs@FDA.
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.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/fda-roundup-june-18-2024-302176037.html
SOURCE U.S. Food and Drug Administration