Topic:

Regulatory

Latest Headlines

Latest Headlines

Extended-release drugs to face extra scrutiny from FDA's new Office of Pharmaceutical Quality

"Modified release is a high-risk area, so we're going to put a lot of emphasis on it," said the deputy director of the FDA's new Office of Pharmaceutical Quality, Lawrence Yu, during a press conference describing the new division.

Stakeholders look for clues to FDA's 2015 intentions regarding health IT

Surprisingly, the issuance of its draft guidance on medical device interoperability was on the "B-list" of guidance that the FDA hopes to publish in the upcoming year, as opposed to the "A-list" of guidance that will mostly likely be published.

FDA steps in after a patient on Antares' 'low-T' drug breaks out in hives

The FDA wants more safety data on Antares Pharma's testosterone treatment after noting a case of hives in a clinical trial, presenting a costly delay for the company's plans to hit the market.

Woodcock kicks off FDA's new Office of Pharmaceutical Quality

On Monday, the FDA launched its long-discussed Office of Pharmaceutical Quality, although a director is not yet in place. Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research, will oversee it until a director is found.

England's Cancer Drugs Fund cuts 25 approvals from list of covered meds

England's Cancer Drugs Fund unveiled its final list of cuts for covered meds, axing 25 cancer treatments to make room for new products and save an estimated £80 million ($121.3 million) a year. 

FDA upgrades Fresenius sterile plant once cited for insect infestation

A Fresenius Kabi sterile manufacturing plant in New York that the FDA cited in 2012 after finding insects in some of the drug vials has earned a reprieve from the agency. The drugmaker said Tuesday that the FDA will allow the APP Pharmaceuticals plant to seek approvals for drugs manufactured there.

FDA approves AbbVie's Parkinson's drug, featuring delivery straight into the GI tract

The FDA just approved AbbVie's novel formulation of the standard Parkinson's drugs carbidopa and levodopa, Duopa, which is delivered straight into the patient's small intestine over 16 consecutive hours using an infusion pump and procedurally placed tube.

UPDATED: FDA stops import of Lilly's Cialis from Australia but Lilly says it doesn't make it there

The FDA issued an import alert on Monday, saying it was banning Eli Lilly's Cialis made at a plant in Australia because testing showed it contained not only the active pharmaceutical ingredient approved for Cialis but also the API that goes in Pfizer's competing erectile dysfunction drug Viagra. The problem, Lilly said in a statement, is that it doesn't currently have a plant in Australia, making Cialis or anything else.

Group wants FDA to include Indian regulators on plant visits

Last year, as tensions grew between the U.S. and India over plants the FDA had banned, the head of the FDA's operation in India said that the agency would start inviting Indian drug inspectors along on plant inspections. The idea was to allow them to learn what the U.S. expected from manufacturers. Now the Indian government is insisting on it.

Vertex's big plans for Kalydeco sales just got bigger

Vertex is already awaiting the FDA's decision on a Kalydeco combo that could exponentially amp up its cystic fibrosis patient pool. But in the meantime, it announced Sunday evening, it's starting in on a Phase III program for yet another Kalydeco pairing.