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Recent news from the US Food and Drug Administration.
Click "read more" links to see the full article at the FDA
website. For the most up-to-date headlines, check out the FDA
Newsroom.
Manufacturer
of Heart Defibrillator Signs Consent Decree of Permanent Injunction
Device manufacturer Physio-Control, Inc., its parent company Medtronic,
Inc., and their two top executives have signed a consent decree of permanent
injunction related to Automatic External Defibrillators (AEDs) manufactured
by Physio-Control, Inc. [ Read
more ]
FDA
Embarks on Major Hiring Initiative for its Public Health Mission
The FDA is hiring hundreds of individuals with science and medical backgrounds
to help meet the agency's responsibilities to assure the safety and/or
efficacy of human and veterinary drugs, biological products, medical devices,
food, cosmetics and products that emit radiation. [ Read
more ]
FDA
Approves Amitiza for IBS-C
The U.S. Food and Drug Administration has approved Amitiza (lubiprostone)
for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C)
in adult women aged 18 and over. [ Read
more ]
Coronary
Artery Plaque Imaging Device Cleared by FDA
The U.S. Food and Drug Administration has cleared for marketing a device
that a doctor can use to see inside a blood vessel to assess the fat content
of the plaque which builds up on the wall of the coronary arteries. [
Read
more ]
FDA
Approves Relistor for Opioid-Induced Constipation
The U.S. Food and Drug Administration today approved Relistor (methylnaltrexone
bromide) to help restore bowel function in patients with late-stage, advanced
illness who are receiving opioids on a continuous basis to help alleviate
their pain. [ Read
more ]
FDA
Orders Pet Food Maker to Obtain Emergency Operating Permit
The U.S. Food and Drug Administration issued an order requiring that Evanger's
Dog and Cat Food Co., Inc., in Wheeling, Ill., obtain an emergency permit
from the FDA before its canned pet food products enter interstate commerce.
[ Read
more ]
FDA
Proposes Recommendations for Two Animal Drug Funding Programs
The U.S. Food and Drug Administration has delivered recommendations to
Congress for two programs that provide funding for the review of pioneer
and generic animal drugs. [ Read
more ]
FDA
Strengthens Safeguards for Consumers of Beef
The U.S. Food and Drug Administration today issued a final regulation
barring certain cattle materials from all animal feed, including pet food.
The final rule further protects animals and consumers against bovine spongiform
encephalopathy (BSE, also known as "mad cow disease"). [ Read
more ]
FDA
Clears Glove Made from New Type of Latex
The U.S. Food and Drug Administration has cleared for marketing the first
device made from a new form of natural rubber latex, guayule latex. The
product, the Yulex Patient Examination Glove, is derived from the guayule
bush, a desert plant native to the Southwestern United States. [ Read
more ]
FDA
Approves Cimzia to Treat Crohn's Disease
A new drug has been approved to help sufferers of Crohn's disease, the
U.S. Food and Drug Administration announced today. Cimzia (certolizumab
pegol) received approval for adults with moderate to severe Crohn's disease
who have not responded to conventional therapies. [ Read
more ]
FDA
Approves First Compact Heart Assist Device
The U.S. Food and Drug Administration today approved a heart assist device
with a novel design that is the first to mechanically support the weakened
heart of a small-sized adult man or woman with heart failure who is at
risk of dying while awaiting a heart transplant. [ Read
more ]
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