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FDA

Latest Headlines

Latest Headlines

India's Sun says slow and steady on Ranbaxy plants, FDA on Wockhardt at odds with management

Manufacturing woes in India continue in the spotlight, though Sun Pharmaceuticals says it will focus on one plant at a time to restore the fortunes of four Ranbaxy manufacturing units banned by the U.S. FDA.

FDA advisers back an approval for Sprout's twice-rejected female libido drug flibanserin

An FDA advisory committee has given Sprout Pharmaceuticals a thumbs up on its quest to gain the first approval ever for an experimental therapy designed to heighten women's sexual desire--but the panelists also want some postapproval studies to help clarify the safety issues involved.

Indian telemarketer of foreign-made drugs goes to federal prison

The FDA has for years been chasing after illegal online pharmacies that sell unapproved, sometimes counterfeit, drugs to consumers. In a new twist on that scheme, the FDA brought a case against a man who worked for an Indian company that was telemarketing directly to consumers prescription drugs made outside the U.S.

Indian industry acknowledges some compliance shortcomings, survey finds

The FDA has banned nearly two dozen plants operated by Indian drugmakers in the past two years, leading some in India's industry to complain that the FDA has it in for the country's drugmakers. It is a contention that the FDA denies. Now, a new survey by a private consulting firm shows that a lot of industry insiders in India recognize there are shortcomings in compliance at their companies.

Khosla-backed Thync dodges FDA, heads to market with $299 mood-shifting consumer wearable

Startup Thync has started to sell its forehead-adhesive consumer device intended to make users feel "more calm or energized" after FDA exempted the system from any regulation as a medical device. The startup said it is the first consumer wearable device that's marketed to improve a person's mood.

FDA study of couples' DTC ad viewing moves forward, but should it?

The FDA is intent on studying the potential influence a spouse may have when patients view DTC ads on television. But the pharma marketing industry has its own questions--mostly, what is the FDA thinking?

Teva a winner as U.S. Federal Court gives thumbs down to Japan's Otsuka on novel Abilify lawsuit

A U.S. federal court ruled against Japan's Otsuka Pharmaceutical in an intricate court case involving an orphan drug, several patents and generics approvals. All of that was involved in a suit against the U.S. FDA.

Report: Claris Lifesciences injectables sale may hit roadblock by FDA Form 483

The Business Standard of India reports plans by Claris Lifesciences to sell its generic sterile injectables business may be thwarted by an adverse observation letter the company is reported to have gotten from the FDA.

FDA to allow midstream changes to device trials as part of effort to speed up approvals

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, Wockhardt among FDA recalls as India manufacturing woes continue

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.