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FDA

Latest Headlines

Latest Headlines

UPDATED: FDA announces intention to comprehensively regulate lab-developed tests

FDA announced July 31 that it intends to issue a draft guidance soon that would require moderate and high-risk diagnostics to obtain 510(k) or PMA approval, regardless of their place of origin, putting an end to a battle to regulate laboratory-developed tests that's been waged for several years.

Muscular dystrophy biotechs buoyed by FDA's encouragement on accelerated OKs

The FDA's Janet Woodcock may be Sarepta CEO Chris Garabedian's favorite person today.

Report of Form 483 for Cadila wreaks havoc with its shares

Given the publicity that has come with FDA bans on a growing list of Indian facilities, even a report of an FDA shortfall at a plant can have consequences these days. That is where India's Cadila Healthcare found itself Thursday when news that it received an FDA Form 483 took a big bite out of its market cap.

Want to claim a name? FDA needs your input on locking down brand monikers

Advertising experts have a few tricks up their sleeves when concocting a drug's proprietary name--like Zytiga, Xtandi and Xeljanz--that might thrust the product to success. Now, the FDA is looking for ideas about allowing drugmakers to reserve these names in advance--with a few rules.

Name-calling: The FDA needs your ideas for locking down brand monikers

Advertising experts have a few tricks up their sleeves when concocting a drug's proprietary name, which might just thrust the product to astounding success. And now, the FDA is hinting that it might allow drug companies to reserve these names in advance--with a few rules.

French devicemaker faces FDA scrutiny for prostate cancer device

French devicemaker EDAP TMS SA is facing FDA scrutiny for its robotic device for prostate cancer, as regulators questioned the product's safety and efficacy in a new report. 

Opinion: Experimental medical devices should be made available to patients

Patients should have the option to take more risks when seeking medical treatment, said Dr. Kevin Tracey in a  Wall Street Journal column.

FDA warns hospitals that Texas compounder's products are unsafe

Most companies voluntarily recall products, and sometimes even stop production, when they or the FDA find quality issues. In the case of a Texas compounder, the FDA has formally requested that it halt sterile drug work and pull back all of its sterile products.

FDA again warns that Texas compounder's products may not be sterile

The FDA continues its battle with a Dallax, TX compounding pharmacy which it says is not meeting sterility standards.

FDA in search of a new head for its Indian operations

When India-born Altaf Lal was named to run the FDA office in India last year, he pledged to work with Indian drugmakers there to improve quality and their chances of avoiding regulatory actions by the agency. But someone else will have to take on that challenge because Lal has left after just about 9 months on the job.