SILVER
SPRING, Md., June 21,
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 published final guidance titled Circumstances
that Constitute Delaying, Denying, Limiting, or Refusing a Drug or
Device Inspection. This guidance defines the types of behaviors
(actions, inactions, and circumstances) that FDA considers to
constitute delaying, denying, or limiting inspection, or refusing
to permit entry or inspection for the purposes of section 501(j) of
the Federal Food Drug & Cosmetic Act. The examples used in this
guidance are not intended to serve as an exhaustive list; rather,
they illustrate the most common situations that FDA has encountered
in preparing for and conducting drug or device inspections as well
as situations that FDA anticipates may occur. FDA does not
interpret the four terms describing prohibited behavior (delay,
deny, limit, refuse) necessarily to be mutually exclusive.
- On Thursday, the FDA issued final Guidance for Industry #278,
Human User Safety in New and Abbreviated New Animal Drug
Applications, to clarify the current approaches and the FDA's
recommendations for Human User Safety (HUS) assessment and
submission of HUS information to support the overall safety of
proposed new animal drugs prior to approval. The guidance is
intended for sponsors interested in pursuing the approval, or
conditional approval, of new animal drugs (including new generic
animal drugs) and is also intended for veterinary health
professionals and the general public interested in understanding
the general principles of HUS assessment for new animal drugs.
- On Thursday, the FDA approved an application for Trimeprazine
with Prednisolone Tablets, which is the first generic of the animal
drug Temaril-P. This generic version is recommended for the relief
of itching regardless of cause. It is also indicated for adjunctive
therapy in various cough conditions of dogs, including for the
treatment of "kennel cough" or tracheobronchitis, bronchitis
including all allergic bronchitis, and infections and coughs of
nonspecific origin. It will be available by prescription only. The
application is sponsored by ZyVet Animal Health, Inc.
- On Thursday, the FDA announced a recall initiated by Cardinal
Health related to the Jiangsu Shenli Medical Production Co Ltd.
recall to stop using its unauthorized plastic syringes. Cardinal
Health recalled affected kits that contain Merit Medical kits with
Jiangsu Shenli syringes. The FDA recommendations have not changed.
We will continue our efforts to evaluate problems with syringes
made in China and keep the public
informed as new or additional information becomes available.
- On Thursday, the FDA announced a new web page and virtual
public meeting dedicated to the Home as a Health Care Hub
initiative. The new web page offers more detail about the
initiative's goals and background. It answers frequently asked
questions, and it's where the FDA will share progress. The FDA will
hold a virtual public meeting on July 25,
2024, from 12 to 4 p.m. ET
(registration required) to provide information about the
initiative, seek input from stakeholders, and start a dialogue
about barriers and opportunities associated with making the home
part of the health care system.
- On Tuesday, the FDA updated the advisory for the investigation
of illnesses linked to Diamond Shruumz-brand Chocolate Bars, Cones,
& Gummies. As of June 17, 2024, a
total of 26 illnesses have been reported from 16 states.
Twenty-five people have reported seeking medical care; 16 have been
hospitalized. No deaths have been reported. Consumers should not
eat, sell, or serve any flavor of Diamond Shruumz-brand Chocolate
Bars, Cones, or Gummies, and should discard them. The FDA will
provide updates as additional information becomes available.
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