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FDA

Latest Headlines

Latest Headlines

UPDATED: FDA finalizes accelerated approval pathway for critical devices, aims to get med tech to market faster

Almost a year after its proposal, the FDA finalized plans for an accelerated review program for critical medical devices and said it will begin accepting applications to participate in the new pathway on April 15.

FDA recalls fall more than 50% in Q1 2015 after reaching record high in 2014

There were 426 medical device recalls in the first quarter of this year, according to FDA's recall database, down from a record high of 968 in Q4 2014.

Does pricier mean better to ad consumers? FDA means to find out

The FDA wants to know how price comparisons in advertising affect people's perceptions of drug quality. The agency's Office of Prescription Drug Promotion is planning a new study to assess how diabetes patients and their doctors react to direct-to-consumer advertisements that feature price info.

FDA approves breath test for stomach disorder, highlights its ease of use over standard of care

The FDA just approved a diagnostic for a troublesome stomach disorder that is easy to perform and does not use radioactive materials.

Alere earns FDA clearance for rapid diagnostic of Strep A

Alere announced FDA clearance of its Alere i Strep A test to detect Strep A bacteria in 8 minutes or less using throat swab specimens.

North Carolina compounder is closed and its products are recalled

For more than two years, the FDA has been very clear about the standards its expects U.S. drug compounders to maintain and the very harsh penalties that can await those who don't comply. But some still haven't heeded the message, and last week North Carolina authorities closed one and the FDA warned providers not to use any of its products.

AstraZeneca gets FDA nod for alternative administration of oral heart med

AstraZeneca's Brilinta can now be crushed and mixed with water or delivered through the nose via a tube, the FDA said, in a move designed to help patients who are unable to swallow the 90-mg tablets whole.

FDA to investigate Bayer's birth control device after allegations of fraud during clinical trial

The FDA has agreed to investigate Bayer's Essure birth control device, following complaints of fraud during the clinical trial and dangerous side effects.

Doctor to pay $2M, pleads guilty to dispensing foreign cancer drugs

The FDA has rolled up yet another doctor in its campaign to punish practitioners who knowingly bought unapproved foreign drugs on the cheap, taking the risk of giving patients ineffective or even counterfeit medications, which some of them ended up doing.

White House calls for advancing rapid diagnostics to combat drug-resistant bacteria

The diagnostics industry will play a significant role in the Obama administration's just-released national action plan to combat the rise of antibiotic-resistant bacteria, such as CRE, which was implicated in the recent death of at least two patients in Los Angeles and many illnesses nationwide.