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Regulatory

Latest Headlines

Latest Headlines

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The window for commenting on the FDA's draft guidance on pharma's use of Twitter and other social media slammed shut last week, leaving the agency with a stack of feedback to consider.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.

Analysis: Treasury Department's move designed to create uncertainty

The Treasury Department's issuance of a notice cracking down on inversions was designed to create uncertainty, says Terry Haines, head of political analysis at investment research firm ISI Group. By that count, the move has succeeded. Questions abound. Will one of the affected companies sue to challenge the legal validity of the agency's action? And what's next? The 42-page notice requests comment and says that the Treasury Department and the IRS expect to issue additional guidance.

Little is known about the Sunshine Act site ahead of launch, AdvaMed says

With just a week to go before the expected release of pharma and med tech companies' payments to physicians under the Sunshine Act, stakeholders are still in the dark about what the website will look like, AdvaMed told FierceMedicalDevices.

FDA moves aggressively on low-T drugs, but replacement pill still aims to enter market

Last week the FDA cracked down hard on low-T therapies. Its expert panel voted to advise the agency to restrict the use of such drugs for a specific medical need.