SeQuent continues to build Indian API assets with Arvee acquisition
Over the past 18 months, India's SeQuent Scientific has won FDA approval of its API plant, sold its specialty chemicals business and acquired a stake in Shasun Pharma. The Bangalore-based business is maintaining the pace and further bolstering its API production business by agreeing to buy Arvee Synthesis.
Report: FDA to inspect more Sun plants in the next few weeks
When the FDA issued an import alert against Sun Pharma's plant in Gujarat in March, the drugmaker reassured investors the facility accounted for just 1% of U.S. sales. But with the allegations of failings at the plant becoming more and more damning, the FDA is reportedly following its now-familiar strategy of going after other facilities in the network.
Power morcellator fallout continues after FDA advisory warning
In the fallout of an FDA advisory that warned of risks tied to a surgical procedure to remove uterine growths, patients and providers remain torn over the safety and efficacy of related devices.
Logistics company RXTPL rails at FDA for identifying it in drug seizure report
The FDA this week sent U.S. Marshals into an Ohio warehouse to seize more than $11 million worth of drugs marketed by Ascend Pharmaceuticals which it claims are unapproved. But a mention in the FDA press release that the drugs were warehoused by Masters Pharmaceutical has brought a world of pain down on the third-party logistics company.
India to double its drug inspection staff
In the face of FDA actions against some of India's biggest drugmakers and a barrage of criticism of its regulators, the Indian government and industry have already responded with a PR campaign, and now India says it will spend more than $500 million to double its inspection staff and upgrade capabilities.
FDA officials say they're 'serious' about pharma's free speech
FDA officials are having a rethink on free speech--and that could end with an about-face on off-label marketing.
FDA weighs the free-speech case for off-label marketing
What with key court decisions apparently backing First Amendment protections for drug promotions, the FDA has moved off-label communications to the top of its to-do list--and off-label marketing is a hot-button issue, what with the series of multibillion-dollar settlements with the U.S. Justice Department.
Should FDA allow drug ads to include price comparisons? A planned study aims to find out
The agency's concern is that consumers could be more swayed by lower prices than by safety and effectiveness--so it's aiming to find out whether that's the case.
FDA balks at accepting all EU plant inspections
The FDA talks a lot about how working with other countries, sharing information and insights, can allow it to stay on top of of the ever-expanding global supply chain while working within a finite budget. But even with Europe, whose geography includes countries as different as the U.K. and Romania, it can be harder to walk the walk than to talk the talk.
Read more: FDA - FiercePharma http://www.fiercepharma.com/tags/fda#ixzz32sWPxne0
Subscribe at FiercePharma
No comments:
Post a Comment