Topic:
Regulatory
Latest Headlines
Latest Headlines
Medtronic launches FDA-targeted study for pain devices
Medtronic is kicking off a large-scale study to expand the FDA indication for its subcutaneous nerve stimulation devices for chronic back pain.
Boston Scientific launches next-gen pain device in the U.S.
Boston Scientific has won the FDA's blessing to launch its Precision Spectra device, pain-relief technology the company says offers better coverage than any product on the market, giving the rebounding devicemaker a broader stake in a fast-growing space.
President's budget takes a big bite out of Medicare drug spending
Expect plenty of teeth-gnashing in the pharma industry over the next several weeks. President Obama's budget proposal not only proposes accelerated discounts for Medicare Part D drugs, but cuts to the Part B program governing treatments administered by doctors.
Feds indict man for selling foreign-made Botox to docs
Federal authorities have come down on an Illinois man and his company, indicting them for importing and selling $3 million worth of foreign and unapproved Botox and Juvederm.
FDA slaps most serious label on Stryker's surgical recall
Stryker has recalled its ShapeMatch Cutting Guides over manufacturing concerns, and now the FDA has assigned a Class I tag to the effort, warning that the devices could lead to serious injury or death.
Hamburg to face Congress again over compounding lapses
FDA Commissioner Margaret Hamburg is again being called before the U.S. House Energy and Commerce Committee, which last year lashed out at her over FDA oversight of compounding pharmacies, one of which is tied to a fungal meningitis outbreak that infected hundreds, dozens fatally.
Acadia soars as FDA green-lights a late-stage shortcut for Parkinson's drug
Shares of Acadia Pharmaceuticals shot up 44% this morning after the San Diego-based biotech announced that the FDA had signed off on a new timeline allowing the biotech to skip a confirmatory late-stage study for their Parkinson's psychosis drug pimavanserin and move straight ahead with a new drug application after tying up some loose ends in the clinic.
FDA wants 11% budget increase for device unit
The FDA is requesting about $870 million to run the Center for Devices and Radiological Health in the next fiscal year, an 11% funding increase over 2012 that the agency says will speed up approvals of new technology.
FDA budget would expand China inspections
With more drugs and ingredients coming from outside the U.S., the FDA has been taking a harder look and a tougher stance on how foreign manufacturers are standing up to its standards.
Pfizer breast cancer hopeful nabs FDA's 'breakthrough' label
Pfizer won coveted "breakthrough" status from the FDA for its experimental breast cancer drug palbociclib after impressive interim results from a mid-stage study.
