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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
Awards $5.2 Million in Grants to Further Food and Feed Safety (September
30)
The U.S. Food and Drug Administration today announced the awarding of
17 grants to enhance food and feed safety. These grants fund major cooperative
agreements in four major areas. The FDA awarded a combined $5.2 million
in these one-year grants to various state and local regulatory agencies.
[ Read
more ]
FFDA
Awards up to $2.5 Billion to Modernize Information Technology over Ten
Years (September 30)
The U.S. Food and Drug Administration today announced the selection of
ten contractors to receive up to a total of $2.5 billion for information
technology (IT) and data center management services over the next ten
years. The contract is the cornerstone of the FDA’s Information Technology
for the 21st Century (ICT21) bioinformatics initiative, an extensive IT
modernization program encompassing data management, data warehousing,
IT infrastructure and IT security. [ Read
more ]
FDA
Analysis Shows Cholesterol Lowering Medications Do Not Increase the Risk
of "Lou Gehrig's Disease" (September 29)
A U.S. Food and Drug Administration's analysis provides new evidence that
the use of statins does not increase incidence of amyotrophic lateral
sclerosis (ALS), a neurodegenerative disease often referred to as "Lou
Gehrig's Disease." The analysis was reported on Monday, Sept. 29,
2008 in Pharmacoepidemiology and Drug Safety. [ Read
more ]
FDA
Updates Health Information Advisory on Melamine Contamination (September
26)
The U.S. Food and Drug Administration (FDA) is alerting consumers that
seven Mr. Brown instant coffee and milk tea products are being recalled
by the Taiwanese company, King Car Food Industrial Co. Ltd., due to possible
contamination with melamine. King Car Food Industrial Co. used a non-dairy
creamer manufactured by Shandong Duqing Inc., China, which was found to
be contaminated with melamine. The recalled products are: [ Read
more ]
FDA
Warns Companies to Stop Marketing Unapproved Ophthalmic Balanced Salt
Solution Drug Products and Topical Drug Products Containing Papain (September
23)
The U.S. Food and Drug Administration (FDA) today announced that companies
marketing unapproved ophthalmic balanced salt solutions (BSS) and unapproved
topical drug products containing papain must stop manufacturing and marketing
these products or risk enforcement action. FDA is taking these actions
because it has received reports of serious adverse events associated with
their uses. [ Read
more ]
FDA
Updates Health Information Advisory on Melamine Contamination (September
23)
On September 12, 2008, in light of reports from China of melamine contaminated
infant formula, the FDA issued a Health Information Advisory to proactively
reassure the American public that there is no known threat of contamination
in infant formula manufactured by companies that have met the requirements
to sell such products in the United States. That advisory also warned
members of Chinese communities in the United States that infant formula
manufactured in China, possibly available for purchase at Asian markets,
could pose a risk to infants. [ Read
more ]
FDA
Updates Health Information Advisory on Melamine Contamination (September
20)
On September 12, 2008, in light of reports from China of melamine contaminated
infant formula, the FDA issued a Health Information Advisory to proactively
reassure the American public that there is no known threat of contamination
in infant formula manufactured by companies that have met the requirements
to sell such products in the United States. That advisory also warned
members of Chinese communities in the United States that infant formula
manufactured in China, possibly available for purchase at Asian markets,
could pose a risk to infants. [ Read
more ]
FDA
Proposes Label Requirements for Refused Imported Foods (September 18)
The U.S. Food and Drug Administration today issued a proposed rule designed
to reduce a practice known as "port shopping" which puts the
safety of imported food at risk. [ Read
more ]
FDA
Issues Draft Guidance on Regulating Genetically Engineered Animals (September
18)
The U.S. Food and Drug Administration, part of the Department of Health
and Human Services, today released for public comment draft guidance on
the regulation of genetically engineered (GE) animals. The guidance document
is intended to clarify the FDA's regulatory authority in this field, as
well as the requirements and recommendations for producers of GE animals
and products derived from GE animals. [ Read
more ]
FDA
Issues Warning Letters to Ranbaxy Laboratories Ltd., and an Import Alert
for Drugs from Two Ranbaxy Plants in India (September 16)
The Food and Drug Administration (FDA) today issued two Warning Letters
to Ranbaxy Laboratories Ltd., of the Republic of India, and an Import
Alert for generic drugs produced by Ranbaxy's Dewas and Paonta Sahib plants
in India. [ Read
more ]
FDA
Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar
and Vaginal Cancers (September 12)
The U.S. Food and Drug Administration today announced the approval of
the vaccine Gardasil for the prevention of vaginal and vulvar cancer caused
by Human Papillomavirus (HPV) types 16 and 18 in girls and women ages
9 to 26. These two HPV types cause 70 percent of cervical cancers, and
are known to also cause some vulvar and vaginal cancers, but the percentages
are not well defined. [ Read
more ]
FDA
Approves Treatment for Rare Neurologic Disease (September 12)
The U.S. Food and Drug Administration today announced that it has approved
an immune globulin product called Gamunex for the treatment of chronic
inflammatory demyelinating polyneuropathy (CIDP), a rare autoimmune disorder
characterized by progressive weakness and impaired sensory function in
the legs and arms. [ Read
more ]
FDA
Issues Health Information Advisory on Infant Formula (September 12)
In response to reports of contaminated milk-based infant formula manufactured
in China, the U.S. Food and Drug Administration (FDA) today is issuing
a Health Information Advisory. This is to assure the American public that
there is no known threat of contamination in infant formula manufactured
by companies that have met the requirements to sell infant formula in
the United States. Although no Chinese manufacturers of infant formula
have fulfilled the requirements to sell infant formula in the United States,
FDA officials are investigating whether or not infant formula manufactured
in China is being sold in specialty markets which serve the Asian community.
[ Read
more ]
FDA:
West Virginia Livestock Owner Sentenced in Criminal and Civil Contempt
Case (September 11)
The U.S. Food and Drug Administration announced today that a West Virginia
cattle dealer has been sentenced to six months probation for refusing
to obey court orders in 2006 and 2008 that prohibited her from introducing
animals into the food supply until the FDA had approved her record-keeping
system. The FDA initiated the case after illegal levels of drug residue
were found repeatedly in calves that Shirley A. Rhodes of Sandyville sold
for use as human food. [ Read
more ]
FDA
to Post Quarterly Report of Potential Safety Issues (September 5)
The U.S. Food and Drug Administration announced today that it has posted
on its Web site its first quarterly report that lists certain drugs that
are being evaluated for potential safety issues. The drugs have been identified
based on a review of reports in FDA's Adverse Event Reporting System (AERS).
[ Read
more ]
FDA
Approves DNA Test to Measure Hepatitis B Virus Levels (September 4)
The U.S. Food and Drug Administration today approved the first nucleic
acid test for hepatitis B virus (HBV) that measures the amount of viral
DNA (viral load) in a patient’s blood. Assessing a patient’s
viral load provides health care professionals with a highly sensitive
method for gauging the progress of antiviral therapy in patients with
chronic HBV infections. [ Read
more ]
FDA:
Manufacturers of TNF-Blocker Drugs Must Highlight Risk of Fungal Infections
(September 4)
The U.S. Food and Drug Administration today announced that the manufacturers
of Humira, Cimzia, Enbrel, and Remicade must strengthen the existing warnings,
in the Warnings and Precaution sections of the drugs' prescribing information
and Medication Guides, on the risk of developing opportunistic fungal
infections. Some patients with invasive fungal infections have died. [
Read
more ]
FDA
Approves Software Update that Identifies Potential Defibrillator Lead
Fractures (September 4)
The U.S. Food and Drug Administration today announced approval of a software
update from Medtronic that will help detect fractures of the company's
Sprint Fidelis cardiac defibrillator lead. The new software package will
alert both patients and physicians of a potential lead fracture. This
will enable early intervention and lower the risk of serious complications.
[ Read
more ]
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