Drug Competition Action Plan Archives

FDA: Record Number of Generic Drug Approvals

Abbreviated New Drug Applications (ANDAs), Approvals, Drug Competition Action Plan, FDA, FDA/Regulatory, Generic Drug User Fee Amendments, Generics, Tentative Approvals, Yale University

The U.S. Food and Drug Administration reported 1,171 generic drug approvals (935 full approvals and 236 tentative approvals) for fiscal year 2019, up from the previous all-time record total of 971 during 2018.

Statement from FDA Commissioner Scott Gottlieb, M.D., on new policy to improve access and foster price competition for drugs that face inadequate generic competition

Abbreviated New Drug Applications (ANDAs), Commissioner, Competitive Generic Therapies, Department of Health and Human Services (HHS), Draft Guidance, Drug Competition Action Plan, FDA/Regulatory, Generics

“We have been taking new policy steps at the FDA to support downward pressure on drug prices by helping to clear a path for more efficient generic development,” says FDA Commissioner Scott Gottlieb, M.D.

As Congress struggles with healthcare reform, Gottlieb’s FDA is taking action

Apps, August 2017, Commissioner, Congress, Digital Health, Digital Health Innovation Plan, Drug Competition Action Plan, FDA/Regulatory, Generics, John Kamp, Obamacare/Affordable Care Act (ACA), Opioids, Wall Street, White House

While the nation’s media was focusing on the unsuccessful attempts by Republicans to pass a successor to Obamacare, a fascinating sideshow has developed in nearby White Oak, Maryland, home of the Food and Drug Administration.