Topic:

Regulatory

Latest Headlines

Latest Headlines

Wockhardt smacked by state regulator in India

Some Indian regulators appear to have heeded FDA Commissioner Margaret Hamburg's call to set a higher bar for manufacturing quality. India's Wockhardt, already in deep trouble with the U.S. and Europe for slacking off on quality, says one of its products has been banned by a state regulator in Himachal Pradesh.

AdvaMed casts a skeptical eye at FDA's new expedited approval idea

AdvaMed is taking a wait-and-see approach on the FDA's just-released draft guidance that describes a new program known as Expedited Access PMA for groundbreaking medical devices that are intended to treat or diagnose life-threatening or irreversibly debilitating conditions.

Mylan launches first generic transdermal contraceptive patch

Mylan Pharmaceutical's Xulane is the first generic contraceptive transdermal patch to hit the market, marking another milestone for the delivery technology.

NICE rejects Roche's hot new breast cancer drug Kadcyla, then invites negotiations

Let the price negotiations begin, the top executive for the U.K. price watchdog suggested today after the agency nixed Roche's pioneering breast cancer drug Kadcyla as too expensive.

Lilly nabs FDA approval for its blockbuster cancer hopeful ramucirumab

Eli Lilly reached the FDA finish line with its cancer treatment Cyramza (ramucirumab), its star oncology candidate.

FDA proposes fast-track program for medical devices

The FDA is proposing expedited premarketing approval of devices that meet an unmet medical need for severe conditions.

Pfizer to plunk down $190M to wrap up Neurontin class action

In the latest settlement of a Big Pharma-delays-generics case, Pfizer has agreed to pay $190 million to wrap up a class-action suit over its seizure drug Neurontin. More than a decade old, the lawsuit claimed that Pfizer did some fast tap-dancing to prolong its Neurontin monopoly.

Teleflex hit with FDA warning letter over respiratory devices

The FDA has handed a warning letter to Teleflex, citing manufacturing issues at an Illinois plant that produces nebulizers, humidifiers and other respiratory technologies.

AbbVie heads to the FDA with its hep C combo in a race with Gilead, Merck

AbbVie has submitted an FDA application for its promising all-oral hepatitis C treatment, expecting approval this year as it prepares for a three-way race with perceived leaders Gilead Sciences and Merck.

FDA issued import alert after importer tried to ship saline not approved in U.S.

The FDA says the recent import alert imposed on 0.9% sodium chloride made at a Baxter International plant in Canada was issued because an "importer/consignee" tried to ship some into the U.S. The problem is, the saline made at that plant is not approved for sale in the U.S.