Critics say a shift in the FDA’s approach toward regulation has allowed manufacturers to seek approval using smaller, shorter, less rigorous studies that provide less certainty of safety and effectiveness.
The warning from the Food and Drug Administration on Wednesday cited recent data pointing to a sharp increase in underage use of the handheld nicotine devices, including Juul, Vuse and others.
The reformulated drug, sold as Narcan, comes as a nasal spray and should help first responders, police and others deliver the antidote in emergency situations.
The FDA has approved a new weight loss drug from Vivus Inc. that many doctors consider the most effective therapy in a new generation of anti-obesity pills designed to help patients safely shed pounds.
The FDA has approved a new weight loss drug from Vivus Inc. that many doctors consider the most effective therapy in a new generation of anti-obesity pills designed to help patients safely shed pounds.
