The U.S. Food and Drug Administration (FDA) has announced details of its long-awaited reorganization of the Office of Generic Drugs (OGD).
The U.S. Federal Trade Commission has announced plans to increase probes into pharmaceutical deals that potentially harm competition by delaying the launch of generic drugs on the market.
Generic pharmaceuticals manufacturers from Europe and the United States have urged regulators on both sides of the Atlantic to adopt a strategy of “regulatory convergence.”
A senior official with the U.S. FDA has slammed research that suggests many heart drugs produced outside the U.S. contain impurities.
Doctors and researchers have criticized the U.S. Food and Drug Administration (FDA) for failing to control the effectiveness of the vast majority of pharmaceutical products sold in the United States.
The European Medicines Agency and the U.S. Food and Drug Administration have started a joint program for sharing information on bioequivalence studies required during the process of approval for generic drugs.