The FDA issued draft guidance this week on adaptive designs for medical device clinical studies. Similar to a prior guidance on the incorporation of patient preference data in clinical trials, the latest guidance should help companies perform trials faster, and signals greater flexibility on the behalf of the FDA.
Cipla and Wockhardt each announced drug recalls from the U.S. market, the former because of failure to meet specifications, the latter because of U.S. FDA concerns about two of its India plants. A Japan devicemaker also announced a U.S. recall.
Momentum is building at the FDA for an overhaul of DTC advertising. That familiar--and often lampooned--recitation of side effects is looking more and more like an endangered species.
Johnson & Johnson's once-a-month antipsychotic med Invega Sustenna is already raking in blockbuster numbers, but the company is eyeing even bigger sales for its franchise with FDA approval for a longer acting formula.
India's Wockhardt faces a tough road to travel to revive its fortunes after a spate of trouble with the U.S. FDA since 2013 that saw the closure of two plants and recent product recalls bedevil the company, India's Business Today magazine reports.
The FDA has challenged developers to create algorithms that identify spikes in adverse event data automatically. The challenge is one of several posted by the regulator to encourage developers to use the data made available through the openFDA initiative and share their work on Reddit.
India-based Wockhardt's U.S. unit has ordered a national recall of 93,393 bottles of its Captopril heart and hypertension drug for being of the wrong thickness. The U.S. FDA also announced recalls of two Japan-made devices.
Startup Intact Vascular expects the $38.9 million Series B it has raised will help it get its peripheral artery disease implant and delivery system into pivotal testing and through the FDA. It's been a long time since the company's $15.5 million first institutional round in September 2012.
After listening to the head of FDA's device arm (CDRH), Dr. Jeff Shuren, speak at several conferences, certain lines become predictable and repetitive. One of them is a boast about the January 2015 approval of the Maestro Rechargeable System on the basis of a patient survey which found that the subjects had a higher risk tolerance than anticipated.
Ranbaxy Laboratories and its new parent, Sun Pharmaceutical Industries, have been named in a U.S. district court suit accusing Ranbaxy of racketeering by blocking generics of two drugs, one each by Roche and Novartis.