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FDA

Latest Headlines

Latest Headlines

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The window for commenting on the FDA's draft guidance on pharma's use of Twitter and other social media slammed shut last week, leaving the agency with a stack of feedback to consider.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.

Hamburg called on to resign for FDA's approval of Zohydro

The FDA approved opioid painkiller Zohydro nearly a year ago as a med to provide relief for those with chronic pain. But the drug has been nothing but 11 months of aggravation for the agency and its leader, Commissioner Margaret Hamburg, who is now being called on to resign by organized anti-addiction groups who say the FDA has contributed to an epidemic of abuse in the country.

Medtronic gains approval, launches Tyrx antibacterial envelope in Europe

Already cleared by the FDA last year, the Tyrx Absorbable Antibacterial Envelope has won a CE mark for use with cardiac devices, and Medtronic has launched it in Europe.

Court ruling against FDA enables more combination products to be classified as devices

The U.S. District Court for the District of Columbia rejected the FDA's attempt to classify Prevor's Diphoterine Skin Wash as a drug rather than a device for the second time, dealing industry a victory in the sometimes contentious arena of product classification decisions.

FDA procedural delay on Rytary gives Impax breathing room

The FDA has put off reconsideration of Impax Laboratories' Parkinson drug Rytary. The delay will give the California company some additional time to work on the latest in a series of FDA concerns over its manufacturing that have kept the drug sidelined.

More FDA issues arise for Hospira in India

About three months before Hospira closed on its acquisition of an API plant from India's Orchid Chemicals & Pharmaceuticals, FDA inspectors made a visit to the facility in Waluj. They had concerns with what they found.