Topic:

Regulatory

Latest Headlines

Latest Headlines

Credit Suisse: FDA 483 unlikely to lead to import alert for Sun

Details of the FDA Form 483 that has loomed over Sun Pharma for the past two weeks have become public. Credit Suisse reports FDA inspectors made 23 observations during a recent inspection of a plant that accounts for up to 25% of Sun's sales, but the regulator found no evidence of data integrity failings.  

Lew's tax rules prompt AbbVie to weigh financing for Shire deal

U.S. Treasury Secretary Jack Lew hasn't scared Big Pharma away from tax inversion deals altogether. But his new rules limiting the benefits of pharma's latest M&A strategy are having some tangible effects already.

EU panel backs slew of new drugs and uses, boosting Lilly, AZ, Novartis, Gilead and more

When Europe's drug approval gatekeepers meet, they often tick off recommendations for some key Big Pharma products. This week, the Committee for Medicinal Products for Human Use backed a whopping 15 new meds and 3 new indications.

Gilead nears EU approval for the next big thing in hep C

Gilead Sciences, already a trailblazer in hepatitis C treatment, is creeping up on its next milestone: approval for a combination therapy that promises to cure the majority of patients without the need for painful injections.

FDA's Mini-Sentinel set to graduate on October 1

The FDA's Mini-Sentinel has long since outgrown its "mini" moniker and is now ready to graduate from being a pilot project to being an integral part of the agency's drug-safety infrastructure. Many people welcome the program's progress, but doubts and dissenting voices remain.

BIO, PhRMA seek FDA reassurance over scope of Twitter guidance

The window for commenting on the FDA's draft guidance on pharma's use of Twitter and other social media slammed shut last week, leaving the agency with a stack of feedback to consider. Many of the respondents are unhappy with the draft, which was called unconstitutional and overbroad.

FDA clarifies '5 unit' rule in custom device exemption guidance

The FDA yesterday issued a guidance on its custom device exemption for devices "created or modified in order to comply with the order of an individual," such an orthopedic joint made especially for a 7-foot patient.  

At least 23 digital health apps clear FDA this year

There have been roughly two dozen digital health-related FDA clearances so far in 2014.

Pfizer preps its case for FDA pulling Chantix's black-box warning

The FDA polished up the official label on Pfizer's stop-smoking drug Chantix earlier this week. It was a victory for Pfizer, the payoff from several studies testing the drug for psychiatric side effects. Essentially, the new label will include study data suggesting that patients using the drug might not be at a greater risk of psychiatric problems after all.

Hey, Big Pharma: When the feds swoop in, be nice. It worked for Shire

Shire and the U.S. Justice Department have come to terms: The Ireland-based drugmaker agreed to pay $56.5 million to settle a variety of alleged marketing violations. So far, so familiar, given the long list of pharma companies that wrapped up similar investigations.