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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.
FDA
Approves First Nucleic Acid Test to Screen for Additional Types of HIV
in Donated Blood and Tissue (December 30)
The U.S. Food and Drug Administration today approved the cobas TaqScreen
MPX Test, the first nucleic acid test that screens for the presence of
two divergent types of HIV in donated blood plasma and tissue. [ Read
more ]
FDA
Approves Drug for Patients with Advanced Prostate Cancer (December 29)
The U.S. Food and Drug Administration recently approved the injectable
drug degarelix, the first new drug in several years for prostate cancer.
[ Read
more ]
FDA
Approves First Imaging Agent to Enhance Scans of Blood Flow. Helps detect
possible blood vessel problems. (December 24, 2008)
The U.S. Food and Drug Administration today approved Vasovist Injection
(gadofosveset trisodium), the first contrast imaging agent for use in
patients undergoing magnetic resonance angiography, or MRA, a minimally
invasive test for examining blood vessels. [ Read
more ]
FDA
Warns Consumers About Tainted Weight Loss Pills (December 22)
List increases from 28 to 69 products; Agency seeking recalls.
The U.S. Food and Drug Administration is expanding its nationwide alert
to consumers about tainted weight loss pills that contain undeclared,
active pharmaceutical ingredients. On December 22, 2008, FDA warned consumers
not to purchase or consume 28 different products marketed for weight loss.
Since that time, FDA analysis has identified 41 more tainted weight loss
products that may put consumers’ health at risk.
[ Read
more ]
FDA
Obtains Injunction to Stop Production of Illegally Medicated Animal Feed
(December 22)
Milbank Mills Repeatedly Violated Manufacturing Regulations
The U.S. Food and Drug Administration announced today that the District
Court for the Western District of Missouri entered a Consent Decree on
Dec. 15, 2008, prohibiting Milbank Mills, an animal feed mill in Chillicothe,
Mo., from manufacturing, processing, or distributing medicated animal
feed. Milbank Mills and its officers Edward P. Milbank and Darrell L.
Allen, face these restrictions until they comply with current Good Manufacturing
Practice (cGMP) requirements for medicated animal feeds. [ Read
more ]
FDA
Approves Gleevec to Prevent Recurrence of Rare Gastrointestinal Cancer(December
19)
The U.S. Food and Drug Administration today approved Gleevec (imatinib
mesylate) for a new indication – keeping cancer from growing in patients
following surgical removal of a gastrointestinal stromal tumor or GIST.GIST
is a fairly rare form of cancer that originates in cells found in the
wall of the GI tract. [ Read
more ]
Historic
Building One Dedicated at FDA’s White Oak Federal Research Center (December
18)
The General Services Administration's National Capital Region (GSA/NCR),
the U.S. Department of Health and Human Services (HHS), and the HHS Food
and Drug Administration (FDA) today dedicated historic Building One at
the White Oak Federal Research Center in Silver Spring, Md. [ Read
more ]
FDA
Approves Drug that Boosts Stem Cell Yield for Bone Marrow Transplants
(December 18)
The U.S. Food and Drug Administration today approved Mozobil (plerixafor),
a drug that helps increase the number of blood stem cells for bone marrow
transplantation in patients with certain forms of blood cancer. [ Read
more ]
FDA
Announces New Recommendations on Evaluating Cardiovascular Risk in Drugs
Intended to Treat Type 2 Diabetes (December 17)
The U.S. Food and Drug Administration recommended today that manufacturers
developing new drugs and biologics for type 2 diabetes provide evidence
that the therapy will not increase the risk of such cardiovascular events
as a heart attack. The recommendation is part of a new guidance for industry
that applies to all diabetes drugs currently under development. [ Read
more ]
FDA
Requires Warnings about Risk of Suicidal Thoughts and Behavior for Antiepileptic
Medications (December 16)
The U.S. Food and Drug Administration today announced it will require
the manufacturers of antiepileptic drugs to add to these products' prescribing
information, or labeling, a warning that their use increases risk of suicidal
thoughts and behaviors (suicidality). The action includes all antiepileptic
drugs including those used to treat psychiatric disorders, migraine headaches
and other conditions, as well as epilepsy. [ Read
more ]
Study
Finds Much of Private-Sector Consumer Medication Information Not Consistently
Useful (December 16)
A study released today by the U.S. Food and Drug Administration found
that the printed consumer medication information (CMI) voluntarily provided
with new prescriptions by retail pharmacies does not consistently provide
easy-to-read, understandable information about the use and risks of medications.
[ Read
more ] [ En
Español ]
FDA
Announces Class I Recalls of Two Unapproved Devices (December 15)
The U.S. Food and Drug Administration (FDA) announced a Class 1 recall
today for two unapproved and uncleared devices whose manufacturers claimed
could treat various medical conditions. A Class 1 recall means that there
is a reasonable probability that the use of a device will cause adverse
health consequences or death. [ Read
more ]
FDA
Warns Consumers and Retailers of Botulism Risk from Ungutted, Salt-Cured
Alewives (Gaspereaux) Fish (December 12)
The U.S. Food and Drug Administration is warning retailers and food service
operators not to offer for sale ungutted, salt-cured alewives (also called
gaspereaux fish) from Michel & Charles LeBlanc Fisheries Ltd., CAP-PELÈ,
New Brunswick, Canada, because the fish may contain the Clostridium botulinum
(C. botulinum) toxin. Consumers should not consume the product. [ Read
more ]
FDA
Requires New Safety Measures for Oral Sodium Phosphate Products to Reduce
Risk of Acute Kidney Injury (December 11)
Today, the U.S. Food and Drug Administration announced that it will add
a Boxed Warning to the prescription oral sodium phosphate products Visicol
and OsmoPrep to warn consumers about the risk of acute phosphate nephropathy
(a type of acute kidney injury). Patients routinely take OSP products
to cleanse the bowel before a colonoscopy (colon examination) and other
medical procedures. [ Read
more ]
FDA
Education Program Wins Award (December 9)
"FDA Patient Safety News," the FDA's monthly video series for
health care professionals, has won the Cheers Award from the Institute
for Safe Medication Practices (ISMP) for efforts to improve the safe use
of medical products and prevent medical errors. [ Read
more ]
FDA
Announces Permanent Injunction Against Wilderness Family Naturals LLC
(December 9)
The U.S. Food and Drug Administration today announced that Wilderness
Family Naturals LLC of Silver Bay, Minn., and its owners have signed a
consent decree that prohibits them from manufacturing and distributing
any products with unapproved claims that the products cure, treat, mitigate
or prevent diseases. [ Read
more ]
FDA,
EPA and USDA Conclude That Accidental Release of Genetically Engineered
Cotton Poses No Safety Risk to Humans or Animals (December 3)
The U.S. government announced today that there is no food or feed safety
concern from an incident in which a small portion of an unauthorized genetically
engineered (GE) cotton variety was harvested along with commercially available
GE cotton. [ Read
more ]
FDA
Announces Participants of Pilot Program for Third-Party Certification
of Imported Aquacultured Shrimp (December 3)
The U.S. Food and Drug Administration today announced the participants
in Phase II of its pilot program for voluntary third-party certification
programs for imported aquacultured shrimp. [ Read
more ]
FDA
Teams With WebMD For New Online Consumer Health Information (December
3)
The U.S. Food and Drug Administration and WebMD today announced a collaboration
that expands consumers' access to the agency's timely and reliable important
health information. This joint effort reflects the FDA's emphasis on using
innovative, technology-based strategies to carry out its foremost mission,
which is to promote and to protect the public health. [ Read
more ]
FFDA
Reports Significant Progress in Protecting the Food Supply (December 1)
The U.S. Food and Drug Administration today released a report on its implementation
of the Food Protection Plan that was launched a year ago to protect both
domestic and imported food from accidental and intentional contamination.
The Plan, which outlines strategies for prevention, intervention and response,
is designed to address food safety and food defense for both domestic
and imported products and covers the full lifecycle of food, by encouraging
the building of safety into every step of the food supply chain. [ Read
more ]
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