Topic:
Regulatory
Latest Headlines
Latest Headlines
Court orders immediate access to some emergency contraceptives
You win some, you lose some. That's the state of affairs on emergency contraception today, at least from the FDA's point of view. The government lost its bid to delay open access to some emergency "morning-after" pills--but won court concession on the others.
Australia packager gets FDA warning letter
A warning letter has been issued to Contract Pharmaceutical Services of Australia, which does drug packaging at a plant in the Sydney suburb of New Ryde.
Indian litigation seeks to close Ranbaxy plants
While Ranbaxy's cover-up of shoddy manufacturing eventually led to a guilty plea and a $500 million penalty in the U.S., there have never been any consequences in its home country of India. Recent public outrage has prompted a stir among government officials about the matter, but some in the public are taking matters into their own hands.
FDA official, panelists challenge Avandia safety trial
Dr. Thomas Marciniak, medical team leader of FDA's Division of Cardiovascular and Renal Products, made some expensive promises Wednesday morning before a panel of outside experts tasked with advising the FDA on whether to lift current restrictions on GlaxoSmithKline's diabetes drug Avandia.
Intuitive faces investor lawsuit as da Vinci claims await
Intuitive Surgical may have won its first liability lawsuit over the da Vinci surgical system, but the company now has to contend with ire from shareholders who claim it made misleading statements to inflate its stock price.
Impax cuts 110 jobs tied to problems at plant
Manufacturing problems at Impax Laboratories' California plant first cost the company a drug approval, then a $186 million partnership with GlaxoSmithKline. Now, it is costing 110 workers their jobs.
FDA issues warning letter for Novartis Ebewe plant
Any drug manufacturer that fails to take instructions from FDA is inviting trouble, and that is what Novartis got by releasing products from a Sandoz Ebewe plant after the agency said they had been manufactured using unapproved inspection procedures.
Abbott posts positive MitraClip results as FDA looms
After squeaking by an FDA panel in March, Abbott Laboratories' is touting new study results for its MitraClip device, finding it safe and effective for the treatment of mitral regurgitation, a valve disorder that hampers heart function.
Cook wins 510(k) status for next-gen biliary stent
Cook Medical's new gastrointestinal tract stent won a pivotal 510(k) clearance, allowing the company to build on a European regulatory nod it won a year ago.
FDA officials divided on Avandia safety as panel meeting looms
Ahead of this week's FDA advisory panel meeting, staff reviewers backed a readjudication of the controversial RECORD trial, which found that the GlaxoSmithKline diabetes drug Avandia does not increase cardiovascular death risks.
