Posted by Michael Wonder on 13 Dec 2018
Statement from FDA Commissioner and Director of FDA’s Center for Drug Evaluation and Research on efforts to modernise generic drug labels while maintaining the efficiency of generic development
13 December 2018 - Protecting patient safety is at the core of the FDA’s mission. All FDA-approved drugs have benefits and risks which must be weighed and balanced by health care providers and patients when making decisions about medical therapy.
For our part, the FDA is committed to a thorough, science-based review of the data and information submitted by drug manufacturers and the corresponding product labelling. Our goal is to ensure that the benefits and risks are clearly articulated in drug labelling.
That patients and providers have accurate information. And that the benefits outweigh the risks for the intended patient population.
