Tag:
FDA
Latest Headlines
Latest Headlines
FDA staff backs J&J's Xarelto for heart condition
The staffers' recommendation of approval comes ahead of Wednesday's advisory committee meeting on the expanded use of J&J and Bayer's Xarelto in ACS patients.
FDA in line for new foreign-inspection powers
The latest version of the Prescription Drug User Fee Act, which is nearing passage in Congress, would give the FDA new powers to police imported drug ingredients and inspect overseas facilities, and drugmakers would face new requirements for reporting production problems that might lead to shortages.
FDA review backs Xarelto for big new use in ACS patients
The anticoagulant won a thumbs-up from FDA reviewers ahead of Wednesday's advisory panel meeting, where FDA experts will weigh a lucrative new indication.
FDA convenes hospital glucose sensor summit
The FDA i s convening a day-long, public meeting on June 25, where they want clinicians, researchers, government regulators, the device industry clinical laboratories and others to chime in about the best way to develop clinical validation studies for and judge the performance of diabetes devices.
Senate vote looms on user fee legislation
The Senate could begin voting today on vital user fee legislation for both the medical device and drug industries, Bloomberg reports.
User fee legislation promises better access, speedier reviews at FDA
Bipartisanship is a rare sight in Congress these days, but a top tier of politicos in Washington D.C. says they've managed to hit the sweet spot with new user fee legislation being taken up by the Senate this week.
Study: FDA outpaces the EMA on drug reviews, new approvals
A new study published in the New England Journal of Medicine concludes that an objective look at the data scuttles the whole notion that regulators in the U.S. are too slow when it comes to saying yes to a new therapy.
SNBL mending lab issues, while entangled with animal welfare issues in Israel
Almost two years after receiving an FDA warning letter citing 9 violations at its Everett, WA, laboratory, SNBL USA announced that it remedied 7 of them.
Payers likely to throw up hurdles to Pfizer's new RA drug
You know that old adage: The one with the gold makes the rules? For the latest exhibit, look no further than Pfizer's anticipated rheumatoid arthritis treatment tofacitinib.
Payers likely to throw up hurdles to Pfizer's new RA drug
The FDA may be a new drug's biggest hurdle, but payers are throwing up more obstacles as high-tech treatments get pricier and healthcare costs keep rising.
