Topic:

Regulatory

Latest Headlines

Latest Headlines

Intercept nabs a 'breakthrough' title for its blockbuster NASH contender

Intercept Pharmaceuticals has nabbed the FDA's breakthrough therapy designation for obeticholic acid, a closely watched therapy in the pipeline for a blockbuster NASH indication.

Zeltiq gains as FDA clears fat-freezing applicator for lower temps, faster treatment

Zeltiq Aesthetics gained 4% after it said FDA cleared a new applicator that uses lower temperatures to cut the one-hour treatment time almost in half. Zeltiq's CoolSculpting procedure is cleared by FDA for noninvasive fat reduction in the abdomen, flank and thighs.

Branded drug prices leapt almost 15% last year, led by pain pills, COPD and heart meds

It's no secret that branded drugmakers often rely on price hikes to keep U.S. sales growth coming, especially on older meds whose patents are close to the ends of their lives. But according to new data, prices spiked more than 10% last year--a trend that may fuel the payer backlash that's been steadily mounting.

How should IBM's Jeopardy-winning Watson be regulated?

IBM's artificial intelligence tool Watson is an expert at Jeopardy, but it can't answer the question as to whether the technology should be regulated as a medical device. That decision rests with Congress and the FDA, or perhaps lobbyists.

European regulators chart record year for new animal health products

The European Medicines Agency recommended 20 new veterinary drugs for approval in 2014--the highest number of positive opinions it has issued in the past 5 years in animal health.

FDA ups regulation of defibrillators to include PMA submission, citing patient safety concerns

The FDA issued an administrative order requiring PMA approval for new and existing automated external defibrillators, citing manufacturing issues and pointing to the recall of 2 million of the devices since 2005 as justification for the more stringent regulation.

India tweaks presubmission rules on drugs, trials, devices and other regulated products

India's Central Drugs Standard Control Organization wants to tweak the rules on its presubmission process with agency staff and experts.

Diagnostics makers face regulatory, cost hurdles in animal health market

Between the need to protect food animals from pathogens and the willingness of pet owners to pay top dollar for testing and treatments, the animal health industry represents a huge opportunity for diagnostics makers. In fact, animal-health diagnostics is expected to be a $4.2 billion market by 2018, according to research firm MarketsandMarkets.

U.S. pushing for provision on fair medical device, drug reimbursement in free trade agreement with Asia

Negotiators are debating a section of the planned Trans-Pacific Partnership free trade agreement that would commit the 12 member countries to transparent procedures and fairness in federal medical device   and drug reimbursement decisions, AdvaMed Senior Vice President Philip Agress told  FierceMedicalDevices.

Pakistan's proposed drug-pricing policy, two years in the making, satisfies no one

SINGAPORE-- More than two years in the making, Pakistan's proposed new drug-pricing policy still hasn't won over drugmakers. The country's health ministry proffered a draft that would peg prices to those in India and Bangladesh, with generic prices at 30% less, on average, than the brand price in those neighboring countries.