Topic:

Regulatory

Latest Headlines

Latest Headlines

India faces higher QC costs as Shasun shows value of compliance

Rising recognition of FDA scrutiny and the cost of quality failings have prompted Indian drugmakers to double spending on compliance over the past 5 years, credit rating agency Crisil reports. And Indian investors are increasingly conscious of the value of such investments, with Shasun Pharma seeing its stock jump 16% this week after it got through an FDA inspection with just a Form 483.

India may alter medical device taxation that favors imports

India's medical device manufacturers hope the government's annual budget will address taxation that skews in favor of imported devices.

Sanofi ups the legal ante to block Lilly's Lantus biosimilar

Sanofi has filed another lawsuit against Eli Lilly in hopes of beating back a biosimilar challenge for its top-selling insulin product, claiming its rival's in-development knockoff infringes its intellectual property.

InSite plans 2015 FDA submission for inflammation eye drop with suspended delivery

InSite Vision, working off its eye drop platform with polymer-suspended drug delivery, is planning to submit an NDA in 2015 for its treatment for blepharitis, an eyelid inflammation disease for which there is currently no FDA-approved treatment.

EU's third pay-for-delay action nails Servier, Teva, Mylan and others

European regulators are getting the hang of levying pay-for-delay penalties, rolling up 6 companies in its latest action and fining them more than half a billion dollars in the process.

Zimmer, Biomet hit regulatory speedbump in pending merger

Zimmer's planned acquisition of Biomet may have hit a speedbump, as the U.S. Federal Trade Commission requested additional information regarding the companies' pending deal.

NeuroMetrix gains on FDA clearance of over-the-counter wearable chronic pain device

NeuroMetrix CEO Dr. Shai Gozani told FierceMedicalDevices that the now-FDA-cleared, over-the-counter version of its wearable therapeutic, the Sensus Pain Management System, will enable the company to pursue further innovations to the device that are not possible in the prescription market.

As FDA regulations tighten, report says antimicrobial market headed for a crash

As the FDA continues its effort to phase out antimicrobials, the numbers aren't looking so good for the contracting market.

FDA prepares to weigh risks of uterine fibroid removal tool

After months of warnings and a debate over the safety of laparoscopic power morcellators, the FDA begins its formal decisionmaking process July 10, when the Obstetrics and Gynecology Devices Advisory Committee convenes for two days in what will be one of the agency's most prominent meetings of the year.

Move by French government encourages docs to use Roche's Avastin over Lucentis

Roche's Avastin is often prescribed off label as a cheaper alternative to its Lucentis for treating wet age-related macular degeneration. Now French lawmakers are encouraging the practice as a way to save the country money.