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FDA

Latest Headlines

Latest Headlines

Court rules that FDA cannot rescind 510(k)s without notice and comment procedures

The FDA's powers to reclassify devices were restricted by a federal appeals court ruling that said the agency does not have the inherent authority to reclassify devices. Rather, the FDA must follow Congress' procedural requirements when reclassifying devices, including notice and comment procedures. 

FDA warns of contaminated Chinese meds after toddler suffers lead poisoning

The problem of contaminated cold remedies has once again surfaced in the U.S. More than seven years after diethylene glycol put authorities on high alert, a toddler in New York has suffered from lead poisoning after taking a Chinese cold remedy.

FDA slaps cardiovascular warnings on Roche/Novartis asthma blockbuster Xolair

It was way back in 2009 when the FDA first indicated it was worried about reports of heart attacks and strokes in patients taking Xolair, the asthma treatment co-marketed by Novartis and Roche. Now the agency is taking action, slapping new warnings to the product's label confirming that it's associated with cardiovascular risks.

The FDA commits $16M to track prescription drug use

The FDA has set aside $16 million for tracking which drugs are used, in what combinations and for how long, Regulatory Focus reports.

FDA's Mini-Sentinel set to graduate on October 1

The FDA's Mini-Sentinel has long since outgrown its "mini" moniker and is now ready to graduate from being a pilot project to being an integral part of the agency's drug-safety infrastructure. Many people welcome the program's progress, but doubts and dissenting voices remain.

BIO, PhRMA seek FDA reassurance over scope of Twitter guidance

The window for commenting on the FDA's draft guidance on pharma's use of Twitter and other social media slammed shut last week, leaving the agency with a stack of feedback to consider. Many of the respondents are unhappy with the draft, which was called unconstitutional and overbroad.

FDA clarifies '5 unit' rule in custom device exemption guidance

The FDA yesterday issued a guidance on its custom device exemption for devices "created or modified in order to comply with the order of an individual," such an orthopedic joint made especially for a 7-foot patient.  

At least 23 digital health apps clear FDA this year

There have been roughly two dozen digital health-related FDA clearances so far in 2014.

Pfizer preps its case for FDA pulling Chantix's black-box warning

The FDA polished up the official label on Pfizer's stop-smoking drug Chantix earlier this week. It was a victory for Pfizer, the payoff from several studies testing the drug for psychiatric side effects. Essentially, the new label will include study data suggesting that patients using the drug might not be at a greater risk of psychiatric problems after all.

FDA to weigh in on cybersecurity concerns

Amid growing concern over the cybersecurity of medical devices, the FDA is weighing in on the issue and addressing product safety at an upcoming conference.