Safe, effective, and high-quality generic drugs play a vital role in the U.S. health care system. Our annual report provides an overview of our 2019 accomplishments, which include more than 1,000 generic drug approvals and tentative approvals. This year, the agency approved 107 first generics of medicines that had no generic competition including drugs to treat pulmonary arterial hypertension, breast cancer, seizures, depression, and various infections.
While this marks another accomplished year for the generic drug program, we know what truly matters is that our work results in more treatment choices and greater access to affordable medicines for patients. We continue to take steps under the Generic Drug User Fee Amendments (GDUFA) to improve access to affordable medicines and encourage robust and timely market competition for generic drugs without sacrificing the scientific rigor underlying our generic drug program.
The report released today demonstrates how FDA’s work with industry, the research community, physicians, health care providers, lawmakers, and other stakeholders helps to make our mission of ensuring that Americans have access to safe, high-quality, and affordable medicines a reality.
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