Food and Drug Administration

Fecal transplants to treat C. diff now need FDA approval

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The Food and Drug Administration is moving to tighten regulations around fecal transplants, which research has shown to be an effective treatment for Clostridium difficile infection.

FDA approves new oral drug to relieve constipation from opioid painkillers

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Long-term care residents who experience constipation from taking opioids to manage chronic pain may benefit from Amitiza, an oral drug recently approved by the Food and Drug Administration.

Court upholds $142 million Neurontin verdict

Pfizer must pay $142 million for the marketing and prescribing of epilepsy drug Neurontin for unapproved uses, a federal appeals court has ruled.

Feds should tighten access to common painkillers, legislators say

The Food and Drug Administration should "act without delay" in tightening access to hydrocodone painkillers such as Vicodin, Congressional lawmakers urged in a recent letter. The letter was written by Sen. Joe Manchin (D-WV) and signed by a bipartisan group of five other senators and two representatives.

Becoming wide awake about the dangers of sleeping pills

Becoming wide awake about the dangers of sleeping pills By

There are some people who are able to fall asleep as their head is hitting the pillow. Then there are the rest of us. And if you don't think you know any of us, you're probably wrong.

FDA orders recommended dosages of sleeping pills to be halved

The Food and Drug Administration is requiring manufacturers of certain sleeping pills, including the widely prescribed Ambien, to reduce current recommended dosages.

Invacare signs consent decree to correct wheelchair manufacturing problems

Invacare has signed a consent decree in which the company will fix wheelchair manufacturing problems, the Food and Drug Administration announced.

Unapproved marketing of pressure ulcer drug brings settlement worth up to $48 million

Unapproved marketing of pressure ulcer drug brings settlement worth up to $48 million   By

The unapproved bed sore drug Xenaderm, which was marketed to nursing homes as "Medicaid reimbursed," is the source of a settlement that could reach $48 million for Healthpoint Ltd. and DFB Pharmaceuticals.

GSK agrees to pay $90 million to settle diabetes drug allegations

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GlaxoSmithKline will pay a $90 million settlement to 38 states that claimed it unlawfully promoted its diabetes treatment Avandia (rosiglitazone). The attorneys general of several states confirmed the action on Thursday.

Senator calls for an end to misleading wheelchair and scooter advertisements

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The aggressive marketing of power wheelchairs and scooters to seniors drives up Medicare costs and puts providers in a tough spot, says Sen. Richard Blumenthal (D-CT).

FDA user fees legislation signed into law

President Obama signed the Food and Drug Administration user fees bill into law on Monday. The measure reauthorizes user fees paid by medical device and drug companies and creates new user fee programs for generic drugs and bio-similar (or follow-on biologic) drugs. In addition, the measure creates regulatory provisions affecting drugs and devices. These include antibiotic development incentives, shortage prevention provisions and new guidance for related social media activities.

FDA endorses safety measures for long-acting opioid painkillers

Companies that manufacture opioid painkillers must underwrite training and educational programs for the physicians who prescribe them, according to a new federal safety measures announced Monday.

Nursing home antipsychotic legislation set aside

Nursing home antipsychotic legislation set aside By

The U.S. Senate did not approve legislation that would strengthen regulations for antipsychotic use in nursing homes, despite overwhelmingly passing a bill it was attached to on Thursday.

Drugs, the lottery and your company's future

Drugs, the lottery and your company's future By

Having recently plunked down a $120 co-pay for medicine that was a far cry from designer caliber, I can relate to people who believe drugs are too expensive.

Higher dose of Alzheimer's drug approved despite FDA warnings, report shows

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Makers of the Alzheimer's drug Aricept released a higher dosage version of the medication despite concerns about side effects and reduced efficacy, a study reports.

FDA warns of risk of anemia drugs

Medications given to treat anemia in kidney and cancer patients greatly increase the risk of cardiovascular problems and need to be used more conservatively, the Food and Drug Administration has said.

Study: Atypical psychotropics are not more dangerous than conventional antipsychotics

Atypical antipsychotic medications are no more dangerous than other conventional antipsychotics, antidepressants and benzodiazepines when it comes to treating nursing home residents, according to a new study.

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