Topic:

Regulatory

Latest Headlines

Latest Headlines

FDA announces LuSys Labs' recall of its unapproved Ebola diagnostic

The FDA cracked down on San Diego's LuSys Laboratories for selling an unapproved diagnostic for Ebola. It announced that the company recalled all 2,000+ units of its Ebola Virus One Step Test Kits in March and destroyed any remaining kits. It deemed the recall Class I, meaning exposure to the violative "product will cause serious adverse health consequences or death."

AstraZeneca's Onglyza 'mortality' risks noted by FDA reviewers

FDA staff reviewers have raised serious concerns about the safety of AstraZeneca's Onglyza ahead of an advisory committee review Tuesday, which could result in a recommendation of a label change for Onglyza as well as other drugs in the DPP4 inhibitor class. 

Study says no good has come from FDA's action on gout drug colchicine

A stink was raised a few years back when the FDA asked for a safety study of colchicine, an inexpensive drug that had been prescribed for decades for gout, then granted exclusive approval to one company who stepped up. As soon as the approval was in place, the price of the drug went up from pennies per pill to $5 and patients and doctors screamed foul. Now some researchers have looked into the unintended consequences of that action and found the agency made things worse for patients with the painful condition, with no benefit.

Safety scare with AstraZeneca's diabetes drug could shake up the DPP-4 field

The FDA raised some alarming concerns tied to AstraZeneca's Onglyza ahead of a committee meeting to discuss the safety of so-called DPP-4 inhibitors, sounding a worrying note for a blockbuster class of drugs.

India's Aurobindo Pharma settles U.S. legal dispute with Natrol

India's Aurobindo Pharma has settled a U.S.-based lawsuit related to its acquisition of vitamin and health product maker Natrol from Plethico Pharmaceuticals in exchange for cash payments and a transfer of assets from the previous owner.

Shire's billion-dollar eye drug gets in line for a speedy FDA review

Shire picked up the FDA's promise of a fast review for its new dry eye drug, a treatment the company believes can eventually bring in more than $1 billion a year.

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.

DBV snags a 'breakthrough' tag for its peanut allergy drug

French biotech DBV Technologies picked up the FDA's coveted breakthrough-therapy designation for its in-development peanut allergy patch, promising a speedy review as it works toward Phase III.

International body releases proposal for regulating software as a medical device

The International Medical Device Regulators Forum, known as IMDRF, weighed in on the upcoming generation of computerized medical devices and mobile apps.

AZ's Onglyza has most to lose at FDA safety confab, analysts say

FDA experts will grill a couple of diabetes meds next Tuesday, and the outcome of that debate could put a damper on sales. The drugs: AstraZeneca's Onglyza and Takeda's Nesina, both DPP-4 blood sugar-fighters. The questions: Do they really increase the risk of heart failure? And if so, what's to be done about it?