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Comments to the European Commission on proposed changes to orphan drug policy show much agreement on the need for change, but little agreement on how to make those changes. Read More
Argentina, Brazil, Columbia and Mexico are four of the top five economies and pharmaceutical markets in Latin America, making them prime spots for drugmakers to do business. These four countries also have four of the seven agencies of reference of the Pan American Health Organization. Read More
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