Topic:

Regulatory

Latest Headlines

Latest Headlines

FDA is now reporting recalls still awaiting classification

The FDA says it wants to notify the public more quickly about drug recalls. And so it has started a pilot program in which it will send out notifications of recalls that have yet to be classified.

Report: Industry's regulatory-centric focus for manufacturing will no longer cut it

Quality lapses can lead to regulatory action, which can mean closed plants and so drug shortages. But a new report says that the industry needs to move beyond its focus on what regulators want and dedicate itself to quality for its own rewards, to lower costs and build business.

J&J snags FDA OK for rare blood disorder drug siltuximab

J&J has won FDA approval for a new drug that fight's a rare blood disorder known as multicentric Castleman's disease.

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AdvaMed is taking a wait-and-see approach on the FDA's just-released draft guidance that describes a new program known as Expedited Access PMA for groundbreaking medical devices that are intended to treat or diagnose life-threatening or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