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.
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.
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 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.
Patients should have the option to take more risks when seeking medical treatment, said Dr. Kevin Tracey in a Wall Street Journal column.
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.
The FDA continues its battle with a Dallax, TX compounding pharmacy which it says is not meeting sterility standards.
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.
The FDA issued Paris-based AB Science a warning letter regarding its Kinavet-CA1 canine drug, intended for mast cell tumors in dogs, for allegedly boasting its off-label uses without approval.
The FDA is continuing to push ahead with its openFDA initiative, with this week's rollout of an application programming interface (API) for recall data coming a month after its adverse event system went live. And the regulator plans to maintain the pace throughout the rest of the summer.