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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
Clears Test to Help Doctors Manage Heart Transplant Patients (August 27)
The U.S. Food and Drug Administration today announced it has cleared for
marketing a non-invasive test that uses molecular expression techniques
to assist doctors in managing heart transplant patients post-surgery for
potential organ rejection. [ Read
more ]
FDA
Approves First Bone Marrow Stimulator to Treat Immune-Related Low Platelet
Counts (August 22)
The U.S. Food and Drug Administration today approved Nplate (romiplostim),
the first product that directly stimulates the bone marrow to produce
needed platelets in patients with a rare blood disorder that can lead
to serious bleeding. [ Read
more ]
FDA
Warns Consumers Not to Eat Certain Mussel Products from Bantry Bay Seafood
(August 15)
The U.S. Food and Drug Administration (FDA) is warning consumers against
eating certain frozen cooked mussel products made by Bantry Bay Seafoods,
imported from Ireland, because they may be contaminated with azaspiracid
toxins, a group of naturally occurring marine toxins known to cause nausea,
vomiting, diarrhea, and stomach cramps. [ Read
more ]
FDA
Approves First Drug for Treatment of Chorea in Huntington's Disease (August
15)
The U.S. Food and Drug Administration has approved Xenazine (tetrabenazine)
for the treatment of chorea in people with Huntington’s disease.
Chorea is the jerky, involuntary movement that occurs in people with this
disease. [ Read
more ]
FDA
Warns Consumers About Potential Problems at Two Baltimore Pharmacies (August
8)
The U.S. Food and Drug Administration is warning consumers who filled
prescriptions at The Medicine Shoppe pharmacies located at 8035A Liberty
Road and 5900 Reisterstown Road in Baltimore that they may have received
drugs that were either expired or suspected counterfeit. The FDA is particularly
concerned because a number of the drugs are for serious diseases and could
have an adverse effect on treatment. [ Read
more ]
FDA
Approves 2008-2009 Flu Vaccines (August 5)
The U.S. Food and Drug Administration (FDA) today announced that it has
approved this year's seasonal influenza vaccines that include new strains
of the virus likely to cause flu in the United States during the 2008-2009
season. The six vaccines and their manufacturers are: CSL Limited, Afluria;
GlaxoSmithKline Biologicals, Fluarix; ID Biomedical Corporation of Quebec,
FluLaval; MedImmune Vaccines Inc., FluMist; Novartis Vaccines and Diagnostics
Limited, Fluvirin; and Sanofi Pasteur Inc., Fluzone. [ Read
more ]
FDA
Announces Improved Policies Regarding Transparency, Public Disclosure
for Advisory Committees (August 4)
The Food and Drug Administration today announced several improved
policies and procedures strengthening its management of FDA advisory committees.
The improvements include stricter limits on financial conflicts of interest
for committee members, improved voting procedures, and improvements to
the processes for disclosing information pertaining both to advisory committee
members and to specific matters considered at advisory committee meetings.
[ Read
more ]
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