Topic:

Regulatory

Latest Headlines

Latest Headlines

AbbVie gets out of the way as the EU prepares for trial transparency

Amid a continental push to make more clinical trial results available to the public, the European Medicines Agency has apparently assuaged a former foe in AbbVie, as the drugmaker dropped a lawsuit designed to block the release of data on its blockbuster Humira.

FDA's OK of opioid overdose treatment doesn't quell backlash over Zohydro

In the wake of the controversy over the FDA's decision to approve Zohydro, a pure hydrocodone drug that has no tamper-resistant technology tied to it, FDA Commissioner Margaret Hamburg Thursday used the approval of a new overdose treatment that anyone can carry to make her case that the FDA is just as concerned as everyone else about opioid drug abuse in the country.

Canadian drugmaker's Indian plant joins FDA import ban parade

The FDA has banned a handful of plants from some of India's biggest drugmakers in the last year, actions that have led to grumbling that the regulator is picking on Indian-owned operations. But now a plant in India owned by a Canadian firm has gotten the same treatment, an import alert that blocks products from being shipped to the U.S.

More scrutiny, less pay? U.K. docs collected less cash from pharma in 2013

Pharma's payments to doctors are diminishing on both sides of the Atlantic. A new report in Britain finds that drugmakers forked over £38.5 million ($63.9 million) to doctors last year. That's slightly less than the 2012 total of £40 million.

My sister, and life science's limits

On a cold January morning in 2013, my big sister, Gretchen, took her last, labored breath and died. She was 46. Over the course of her last month alive, I developed a growing sense of anger and desperation at how her doctors, as well as the drug and diagnostics industries, seemed to have failed her.

Hikma earns FDA closeout letter for its New Jersey plant

FDA inspectors paid a return visit to Hikma Pharmaceutical's New Jersey plant in February and found everything satisfactory. The FDA has now issued a closeout letter for the plant that was cited with a warning letter more than two years ago.

Novartis Japan staffers shredded and deleted to cover trial misconduct, panel finds

Novartis' Japanese unit didn't fake clinical data in a head-to-head leukemia drug study, an investigatory panel found. But that doesn't mean the Swiss drugmaker's staff is off the hook in its latest Japanese scandal. According to the panel's report, employees not only broke the rules repeatedly--they also engaged in a cover-up.

GSK recalls Paxil after FDA issues warning letter

GlaxoSmithKline has said it will recall some batches of its antidepressants Paxil and Seroxat because the active ingredient used to make them might have been tainted. But the U.K.-based drugmaker didn't decide to take the step until it was publicly chastised by the FDA about the problem in a warning letter.

Four months later, 23andMe's clash with the FDA remains unresolved

In the four months since 23andMe agreed to stop selling all health-related genetic tests in the U.S. while it submits them for a formal FDA review, the California company's future has become cloudier, not clearer.  A recent blog post on its web site informed customers that executives continue to meet with regulators, but a resolution to the matter doesn't appear to be anywhere close to happening.

Industry predicts dire consequences from FDA's generic labeling proposal

The FDA says it wants to level the playing field by having generic drugmakers independently update drug labels when there are known risks to the products. The industry feels as if it is being nudged off a cliff.