SILVER
SPRING, Md., June 28,
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 updated the advisory for illnesses associated
with eating Diamond Shruumz-brand Chocolate Bars, Cones, and
Gummies to announce that all flavors of Diamond Shruumz-brand
products have been recalled. Consumers should not eat, sell, or
serve any flavor of Diamond Shruumz-brand Chocolate Bars, Cones, or
Gummies, and should discard them. Retailers should not sell or
distribute any flavor of Diamond Shruumz-brand Chocolate Bars,
Cones, or Gummies. Additional instructions on how to return or
dispose of the product are available on the firm's press release.
As part of this investigation, the FDA and state partners have
collected multiple samples of Diamond Shruumz-brand products for
testing and analysis. Additional sample analysis is ongoing, but as
of June 25, 2024 test results for two
individual chocolate bars collected from a retail store have been
reported on the advisory. The FDA and CDC medical officers are
interpreting these test results to understand the health risks of
ingesting these chemical substances and to determine the
appropriate next steps.
- Today, the FDA issued a Constituent Update highlighting the
updated list of draft and final guidance topics that are a priority
for the agency's Foods Program to complete during 2024.
- Today, the FDA announced the draft guidance, Essential Drug
Delivery Outputs for Devices Intended to Deliver Drugs and
Biological Products. The guidance is intended to facilitate and
streamline development of stand-alone devices, and combination
products with device constituent parts, intended to deliver drugs
and biological products, by improving the consistency of drug
delivery performance information included in applications and
submissions. Drug delivery performance information is intended to
demonstrate that the device drug-delivery function consistently
performs as intended. The guidance includes examples of potential
essential drug delivery outputs for several product types including
prefilled syringes, injectors, nasal sprays, and inhalation
devices.
- On Thursday, the FDA published the "Catching Up with Califf:
The Concerning Trend in Men's Health," by Robert M. Califf, M.D., Commissioner of Food and
Drugs. In this article Dr. Califf brings attention to a startling
paradox: despite unprecedented technological advances that have
saved lives globally, and despite spending more on healthcare than
any other nation on earth, life expectancy in the U.S. is trending
downward. Taking a closer look at the data, it's clear that one
group in particular is falling behind—men.
- On Thursday, the FDA announced the seizure of 53,700
unauthorized e-cigarette products valued at more than $1.08 million. The FDA worked with U.S. Customs
and Border Protection to seize the shipment at the Chicago port of entry, though the unauthorized
products were intended for a wholesaler based in Mississippi.
- On Thursday, the FDA released a From Our Perspective blog
titled, "FDA Opens Doors for More Treatments for Rare Diseases
through the New START Pilot Program." Bylined by Dr. Patrizia Cavazzoni, M.D., Director, Center for
Drug Evaluation and Research and Dr. Peter
Marks, M.D., Ph.D., Director, Center for Biologics
Evaluation and Research, the blog shares the names of the selected
pilot program participants and how the pilot will help accelerate
the development of novel drugs and biologics. CBER and CDER look
forward to actively working together to fulfill our shared vision
of accelerating the development of better treatment options for
patients and their families. For questions about the START Pilot
Program, please contact CDER's START Pilot Program mailbox
(CDER.STARTProgram@fda.hhs.gov) or CBER's Office of Communication,
Outreach and Development (ocod@fda.hhs.gov). For additional
information about individual sponsors and products, please contact
the sponsors directly.
- On Thursday, the FDA determined the national supply of
cisplatin now exceeds demand, ending the national shortage for the
important cancer drug. Since the shortage was announced on
February 10, 2023, the FDA has taken
every step within our statutory authority to tackle cancer drug
supply issues, including:
- Working closely with five cancer drug manufacturers to provide
assistance and support their efforts to increase manufacturing
capacity.
- Helping another manufacturer who had previously stopped
producing an approved cisplatin product reenter the market.
- Temporarily exercising discretion not to enforce importation
requirements with regard to cisplatin to help meet patient needs
during the shortage. As with all temporary importation, the product
and manufacturing sites were thoroughly evaluated to help protect
U.S. patients. That manufacturer has since received FDA approval
for cisplatin, bringing the total number of approved manufacturers
to seven.
The FDA will continue to work with drug
manufacturers and health care providers to help restore access to
essential cancer treatments and other medicines that are currently
in short supply.
- On Thursday, the FDA published the Medical Countermeasures
Initiative (MCMi) Program Update report, which showcases the
agency's work each year to prepare for all types of public health
emergencies. Covering fiscal year 2023, the report includes updates
on the FDA's work agency-wide to support development of and access
to medical countermeasures for a variety of public health
threats.
- On Thursday, the FDA announced the 26th Session of the
International Medical Device Regulators Forum that will be held in
Seattle, Washington, on
September 16-20, 2024. Medical device
stakeholders — including regulators, industry, academia, and the
media — are invited to attend a free event that is open to the
public, virtually or in-person, on September
16-17. The last three days (September
18-20) are for IMDRF invitees only. Please note that space
is limited for in-person attendance and early registration is
encouraged. You can also attend the meeting by livestream. The
deadline to register is August 26,
2024.
- On Wednesday, the FDA's Center for Veterinary Medicine and the
European Medicines Agency announced updates to the Parallel
Scientific Advice (PSA) program for new animal drug products to
increase harmonization and facilitate development of new products
to support animal health. The animal drug industry and the agencies
that regulate them are increasingly seeking opportunities to
proactively engage in the early stages of drug product development.
The PSA program allows for animal drug sponsors to engage in
concurrent scientific conversation with both agencies, the FDA and
the EMA, on key issues during the development phase of new animal
drug products.
- On Wednesday, the FDA warned consumers in Safely Soothing
Teething Pain in Infants and Children about the dangers of treating
children's teething pain with medicines containing benzocaine or
lidocaine. Teething is a normal experience for infants and
children. Soothing children's gums with prescription or
nonprescription medicines containing benzocaine or lidocaine – or
homeopathic tablets and other products – might seem like good
options. But those products can be dangerous to children and can
lead to serious injury, and even death.
- On Wednesday, the FDA announced the virtual Medical Device
Sterilization Town Hall: Mock Pre-Submission on Implementing a
Change in Sterilization Method that will be held on
July 10, 1-2:30 p.m. ET. We will present a mock
pre-submission for a fictional medical device and explore
regulatory, design and testing considerations when there is a
change in sterilization method. Registration is not required to
attend.
- On Wednesday, the FDA announced a partnership with the Bill and
Melinda Gates Foundation to create new analytical methods to help
the development of breath-based diagnostic devices for infectious
disease detection in underserved populations, thereby promoting and
fostering health equity. "Guided by our shared interest in
advancing health equity and equality, this partnership can
ultimately open the possibility of widespread disease detection in
medically underserved populations both domestically and globally,"
said CDRH Director Jeff Shuren,
M.D., J.D., and CDRH's Office of Science and Engineering
Laboratories (OSEL) Director Ed
Margerrison, Ph.D. The methods will include a database of
chemical information, criteria for classifying confidence of a
chemical identification and a web application for analysis of mass
spectrometry data. These methods are intended to help drive
confidence in measurement techniques and ultimately reduce risk for
developers, medical device innovators and regulators.
- On Wednesday, the FDA granted accelerated approval to Epkinly
(epcoritamab-bysp), a bispecific CD20-directed CD3 T-cell engager,
for adult patients with relapsed or refractory follicular lymphoma
(FL) after two or more lines of systemic therapy. The most common
adverse reactions (≥20%) were injection site reactions, cytokine
release syndrome, COVID-19 infection, fatigue, upper respiratory
tract infection, musculoskeletal pain, rash, diarrhea, pyrexia,
cough, and headache. The most common Grade 3 to 4 laboratory
abnormalities (≥10%) were decreased lymphocyte count, decreased
neutrophil count, decreased white blood cell count, and decreased
hemoglobin.
- On Tuesday, the FDA announced the availability of final
guidance for industry (GFI) #276 entitled "Effectiveness of
Anthelmintics: Specific Recommendations for Products Proposed for
the Prevention of Heartworm Disease in Dogs." The guidance is
intended for animal drug sponsors interested in pursuing approval
of new heartworm prevention products for dogs. The FDA received
eight comment submissions on the draft guidance, and all comments
were considered as the guidance was finalized. The guidance
announced in the June 25 notice
finalizes the draft guidance dated November
30, 2022.
- On Tuesday, the FDA announced the availability of final
guidance for industry #283 entitled "Priority Zoonotic Animal Drug
Designation and Review Process." The guidance is intended to help
animal drug sponsors pursuing Priority Zoonotic Animal Drug (PZAD)
designation for a new animal drug. PZADs are new animal drugs that
have the potential to prevent or treat a zoonotic disease in
animals, including a vector-borne disease, that has the potential
to cause serious adverse health consequences for, or serious or
life-threatening diseases in humans. This guidance is intended to
help expedite the development and review of these drugs. The FDA
received several comments on the draft guidance, and those comments
were considered as the guidance was finalized. The guidance
announced in the June 25 notice
finalizes the draft guidance dated December
2023.
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