Articles in FDA
GAO: FDA yet to make safety changes post-Vioxx scandal
The FDA still hasn’t restructured its staff to better monitor drug safety, more than three years after experts recommended key changes in the wake of the Vioxx scandal
Medtronic gets FDA warning on documentation, responses, quality control in heart implant unit
The FDA found problems with procedures for preventing and identifying problems with its devices, documenting those problems, and the speed with which it informs the FDA of any issues
FDA warns against mixing Nexium or Prilosec with Plavix
The FDA on Tuesday warned consumers not to take popular heartburn medications Nexium or Prilosec if they use Plavix
Pain Killer Pumps May Themselves Cause Irreversible Joint Damage
Federal regulators are demanding changes to labels on devices that deliver pain killers directly to joints after surgery, in response to numerous reports of irreversible cartilage damage
FDA finds bits of steel, rubber in Genzyme drugs
Federal health regulators have found tiny particles of trash in drugs made by Genzyme, the second time this year the biotechnology company has been cited for contamination issues
Food-borne pathogens carry devastating long-term effects
Seizures, paralysis, mental disability – the lingering problems from eating tainted food can be worse than the acute illnesses right after exposure
FDA questions safety of alcoholic energy drinks
The Food and Drug Administration is challenging makers of alcohol-infused energy drinks to prove their beverages are safe, citing complaints that the products can cause risky behavior and injury
FDA seeks to reduce drug dosage errors
In an attempt to reduce the 1.5 million preventable serious health problems and even deaths caused by misuse of medication, the FDA is trying to identify the most serious threats and find ways to avoid them
Awareness: On Drug Labels, Vital Facts May Be Missing
Federal officials who approve new drugs review an enormous amount of data about their effectiveness and harmful side effects, but critical information often fails to reach the doctors who prescribe them.
FDA fails to follow up on unproven drugs
The FDA has allowed drugs for cancer and other diseases to stay on the market even when follow-up studies showed they didn’t extend patients’ lives, say congressional investigators.
Experts: Key drug facts often left off FDA labels
Much of what the Food and Drug Administration knows about a drug’s safety and effectiveness is not included on the label, say two drug safety experts who are calling on the agency to make that information more accessible.
Three federal agencies to assess potential Lasik eye surgery problems
Aggressive marketing has made Lasik a $2-billion industry, one that has come under criticism for overselling the surgery’s benefits and underplaying its risks.
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.
