Articles in FDA
Pfizer Hit With $1.3 Billion Fine For Bextra Marketing
A federal court has levied a record $1.3 billion criminal fine — the largest ever imposed in the U.S. — against Pfizer Inc. subsidiary Pharmacia & Upjohn Co. Inc. for fraudulently misbranding its anti-inflammatory drug Bextra.
FDA cracks down on Internet sales of swine flu ‘cures’
About 80 Internet purveyors have been warned to stop peddling unproven or illegal treatments for H1N1 such as ultraviolet lights or dietary supplements.
USDA, FDA team up to write new food safety rules
As reported by the SF Chronicle, two federal agencies are teaming up to write new food safety rules for fresh produce, following numerous foodborne illness outbreaks tied to fruits and vegetables in recent years.
Beleagured Food and Drug Administration Reveals It Succumbed to a Push by “Paid-For Lawmakers”
As noted in our Medtronic heart lead recall blog, the New York Times has issued a story that the U.S. FDA “has revealed that four New Jersey congressmen and its own former commissioner unduly influenced the process that led to its decision last year to approve a patch for injured knees,” an approval it is now revisiting.
Much-criticised FDA medical device approvals get external review
The Food and Drug Administration is asking the government’s top medical advisers to review its system for approving certain types of medical devices, which has been criticized by safety advocates and government watchdogs.
FDA confirms new infections linked to Tysabri
The San Francisco Chronicle reports that the FDA has confirmed three new cases of a potentially lethal brain inflammation linked to the multiple sclerosis drug Tysabri.
FDA requires strong amputation warning on injected sedative promethazine
As noted in today’s San Francisco Chronicle, makers of injected promethazine, a sedative also used to treat nausea and vomiting, are being required to put the strongest warning possible on the product because it can cause tissue damage leading to amputation, according to the U.S. Food and Drug Administration.
Parents fight use of new psychiatric medications for kids
The San Francisco Chronicle ran a powerful and disturbing story today on the dangers of newly approved psychiatric medications that are harming and even killing children: as these drugs and sad tales of their effects proliferate, more parents are fighting back.
