We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The European Medicines Agency has outlined the steps companies should follow once they secure orphan status for a medical product to maintain that status and secure marketing authorization. Read More
Generic drug applicants need to get their bioanalytics right when demonstrating bioequivalence to avoid costly delays or outright rejection by the FDA, an agency official warns. Read More
The Office of Generic Drugs had a banner year in 2015, seeing more than 700 full and tentative approvals, the agency announced yesterday in its first-ever report on generics. Read More
The FDA has put the brakes on approving Opko’s secondary hyperparathyroidism candidate Rayaldee, citing third-party manufacturer deficiencies that resulted in a Form 483. Read More
A first cycle approval of a generic drug would ensure quick access in the market and eliminate the need for additional communications with the FDA. However, this may not always be possible, as GDUFA I does not provide for adequate communication between industry and the agency during the presubmission and ANDA review stages, Aloka Srinivasan, a principal consultant at PAREXEL International said in a recent FDAnews webinar. Read More
Teva Pharmaceuticals scored FDA approval for its generic of the blockbuster erectile dysfunction drug Viagra, but it won’t be commercially available anytime soon. Read More
The FDA has made final decisions on roughly two-thirds of the GDUFA backlog of long-standing applications since the program’s fiscal 2013 inception, and met its final hiring goals 11 months ahead of schedule, the agency says in its fiscal 2015 GDUFA report to Congress. Read More