Topic:

Regulatory

Latest Headlines

Latest Headlines

EMA director Rasi sidelined by complaint from colleague who wanted his job

For three years, Guido Rasi has been Europe's top pharma regulator, moving aggressively to restore the image of the European Medicines Agency. But his future there is now in doubt, sidelined by a colleague who was miffed that he was not picked for the job himself, the Financial Times reports.

FDA to Mallinckrodt: Generic Concerta doesn't measure up to J&J's brand

The FDA's new due diligence on generic drugs now has one victim: Mallinckrodt, which makes a knockoff version of Johnson & Johnson's ADHD drug Concerta. The Dublin-based drugmaker says the FDA is questioning whether its generic actually measures up to the brand.

Former top execs at Ranbaxy U.S. open consulting business

Ranbaxy's top U.S. execs were seen as pivotal in the company getting approval to move production of a generic of Novartis' blockbuster Diovan from a banned plant in India to Ranbaxy's New Jersey facility. But a handful of them resigned last month, and now they intend to use that experience helping other drugmakers make it through the FDA's tough maze of regulations, and to negotiate with payers.

FDA clears first patient-specific spinal rod

France's Medicrea Group said it has received FDA clearance for the world's first patient-specific spinal osteosynthesis rod, the UNiD, enabling physicians to order customized rods that match the spinal alignment of each patient.

FDA finds another Indian drugmaker selling contaminated drugs

India's Cadila Pharmaceuticals has run afoul of the FDA for not doing enough to track down the source of impurities in some products and failing to investigate when customers complained about odors emanating from its APIs.

FDA clears syringe that prevents needlestick injuries

Exton, PA's West Pharmaceutical Services just announced that the FDA has given it 510(k) clearance for the NovaGuard Staked-needle Automatic safety system, as the push to avoid needlestick injuries gathers momentum.

Threshold shares surge as PhIII cancer program enters FDA's fast track

Shares of Threshold Pharmaceuticals jumped about 10% this morning on news that the FDA is granting fast-track status to TH-302, the company's sole therapy now in a pair of late-stage cancer studies.

UPDATE: Cadila Pharmaceuticals API plant slapped for faulty follow-up on stinking APIs

When India's Cadila Pharmaceuticals got complaints from customers about some of its APIs smelling bad, the drugmaker decided the odor stemmed from an impurity, so it tweaked the manufacturing process. The problem, according to the FDA, is that the plant never conducted an investigation to determine whether the impurity was in fact the cause, so the company never knew whether it had really resolved the cause of the stench.

Some psych experts want FDA to yank black-box warning on antidepressants

In the 10 years since the FDA found that antidepressants carried an increased risk of suicidal thoughts and behaviors in teens and slapped a black box warning on the drugs, psychiatry experts remain divided on the warnings' efficacy, with some calling for a removal of the label altogether.

UPDATED: China FDA's new medical device importation regulations shorten review period

China's registration review process for imported medical devices and in vitro diagnostics has been shortened under new China FDA importation regulations that took effect last month, and companies that fail to follow the guidelines will not get a second chance, meaning any mistakes could prove fatal to a product's chances in China.