Recent figures published by EMA relating to centralized procedure activities for human medicines appear to show a marked slowdown in the number of generic-drug applications filed and finalized this ...
FDA Talks Generic Drugs: A Look at the Generic Drug Approval Process from the Agency’s Perspective
So you’re preparing an abbreviated new drug application submission… what could possibly go wrong? The Food and Drug Administration responds: Let us count the ways… However, much of it can be avoided ...
Consumers and lawmakers pushing for cheaper alternatives to the EpiPen, an antidote for life-threatening allergic reactions, and other high-priced drugs are seeking answers about a stubborn backlog of ...
Now that the Food and Drug Administration plans to fast-track generic drug applications in hopes of spurring competition and lowering medicines costs, a key question should be asked: Can the agency ...
The Bush administration on Thursday announced new rules that would hurry generic drugs to market by making it harder for the makers of brand-name versions to block the competition. The change, ...
The U.S. Food and Drug Administration and the European Medicines Agency (EMA) today announced the launch of a joint initiative to share information on inspections of bioequivalence studies submitted ...
The FDA signed off on a second generic option for the abortion pill mifepristone on Tuesday, hours before most of the federal government shut down and despite Republican opposition to the drug. Evita ...
PARSIPPANY, N.J. (AP) -- Generic drugmaker Actavis Inc. said Tuesday it has filed an application with federal regulators to market a generic version of the anti-inflammatory drug Rayos. Rayos is ...
Fifty percent of the marketing authorization applications for human medicines submitted to the European Medicines Agency (EMA) in 2009 were for generic and hybrid medicines — 60% higher than the ...
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