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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
Seeks Civil Penalties from Calif. Device Maker (March 28)
The U.S. Food and Drug Administration (FDA) today announced it is seeking
a $2.2 million penalty against a California hearing device manufacturer
for violations of federal law, including manufacturing standards violations
and the failure to notify the FDA of a change in an outside supplier or
vendor, which may have exposed recipients of the devices to unnecessary
health risks. [ Read
more ]
FDA
Warns Consumers about "Total Body Formula" and "Total Body Mega Formula"
(March 27)
The U.S. Food and Drug Administration is advising consumers not to purchase
or consume Total Body Formula in the flavors of Tropical Orange and Peach
Nectar, or Total Body Mega Formula in the Orange/Tangerine flavor. The
liquid dietary supplement products may cause severe adverse reactions,
including significant hair loss, muscle cramps, diarrhea, joint pain and
fatigue. [ Read
more ]
FDA Identifies First Steps in Requirements for Safety Plans for Certain Drugs and Biologics (March 27)
The U.S. Food and Drug Administration has identified 25 drugs and biologic
products that will be required to submit safety plans called Risk Evaluation
and Mitigation Strategy (REMS), the FDA said in a Federal Register notice
published today. [ Read
more ]
FDA
Makes Recommendations on Medical Devices That Treat Blocked Heart Arteries
(March 26)
U.S. Food and Drug Administration Commissioner Andrew C. von Eschenbach
today announced that the agency has issued draft guidelines to aid the
development, testing and manufacture of coronary drug-eluting stents,
devices used to treat blocked heart arteries. [ Read
more ]
FDA
Warns Consumers Not to Use "Blue Steel" and "Hero" Products (March 25)
The U.S. Food and Drug Administration is advising consumers not to purchase
or use "Blue Steel" or "Hero" products marketed as
dietary supplements throughout the United States because they are considered
unapproved drugs and have not been proven to be safe or effective. These
products contain undeclared ingredients, which may dangerously affect
a person’s blood pressure level. [ Read
more ]
FDA
Warns of Salmonella Risk with Cantaloupes from Agropecuaria Montelibano
(March 22)
The U.S. Food and Drug Administration has issued an import alert regarding
entry of cantaloupe from Agropecuaria Montelibano, a Honduran grower and
packer, because, based on current information, fruit from this company
appears to be associated with a Salmonella Litchfield outbreak in the
United States and Canada. The import alert advises FDA field offices that
all cantaloupes shipped to the United States by this company are to be
detained. [ Read
more ]
FDA
Approves New Medical Adhesive to Treat Burn Patients (March 19)
The U.S. Food and Drug Administration today approved a new medical adhesive
(a fibrin sealant) called Artiss for use in attaching skin grafts onto
burn patients. [ Read
more ]
FDA
Takes Next Step in Establishing Overseas Presence (March 14)
In an important development, the U.S. Food and Drug Administration has
received approval from the U.S. State Department to establish eight full
time permanent FDA positions at U.S. diplomatic posts in the People's
Republic of China, pending authorization from the Chinese government.
[ Read
more ]
FDA
Issues Alert on Tussionex, a Long-Acting Prescription Cough Medicine Containing
Hydrocodone (March 11)
The U.S. Food and Drug Administration issued an alert today on the safe
and correct use of Tussionex Pennkinetic Extended-Release Suspension in
response to numerous reports of adverse events--including death--associated
with the misuse and inappropriate use of this potent cough medication.
[ Read
more ]
FDA
Names Permanent Director for Center for Drug Evaluation and Research (March
10)
Commissioner of Food and Drugs Dr. Andrew C. von Eschenbach today announced,
after a national search, the appointment of Janet Woodcock, M.D., as director
of the agency's Center for Drug Evaluation and Research (CDER). [ Read
more ]
FDA
Warns Companies Importing and Marketing Drugs Over the Internet that Fraudulently
Claim to Prevent and Treat STDs (March 6)
The U.S. Food and Drug Administration today issued Warning Letters to
six U.S. companies and one foreign individual for marketing unapproved
and misbranded drugs over the Internet to U.S. consumers for the prevention
and treatment of sexually transmitted diseases (STDs). [ Read
more ]
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