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New drug regulator confronts major challenges

New drug regulator confronts major challenges

By Steven Ross Johnson  |  April 02, 2016

An opioid abuse epidemic fueled by prescription drugs. Public outcry over high drug prices. A huge backlog of generic drug applications. Industry stakeholders pressing for faster approvals. Newly confirmed FDA Commissioner Dr. Robert Califf tops our 50 Most Influential Physician Executives and...

FDA's No. 2 Califf nominated to be next commissioner

FDA's No. 2 Califf nominated to be next commissioner

By Modern Healthcare  |  September 19, 2015

Dr. Robert Califf, 63, is nominated by President Barack Obama to be the next commissioner of the Food and Drug Administration. He would replace Dr. Margaret Hamburg, who stepped down early this year.

Obama nominates FDA's No. 2 official to lead agency

Obama nominates FDA's No. 2 official to lead agency

By Associated Press  |  September 15, 2015

President Barack Obama has nominated the Food and Drug Administration's second-highest ranking official, Dr. Robert Califf, to lead the agency, which regulates consumer products ranging from medications to seafood to cigarettes.

Lobbying groups hungrily eye fast-moving FDA overhaul bill

Lobbying groups hungrily eye fast-moving FDA overhaul bill

By Darius Tahir  |  May 16, 2015

Why is the nation's capital suddenly obsessed with biomedical innovation? And why is the fruit of that obsession, the 21st Century Cures Act, moving like a greased pig through the usually deadlocked Congress—even as some experts warn it could undermine the FDA's ability to protect the public...

Beware a 21st Century Quackery Act

Beware a 21st Century Quackery Act

By Merrill Goozner  |  May 02, 2015

Proposed legislation “modernizing” the Food and Drug Administration's approach to approving breakthrough drugs and devices would undermine the agency's ability to protect the American public from unproven and possibly unsafe new products.

House panel scheduled to release FDA overhaul bill

House panel scheduled to release FDA overhaul bill

By Darius Tahir  |  April 25, 2015

The House Energy & Commerce Committee this week is expected to unveil a revised version of controversial legislation overhauling the Food and Drug Administration's regulatory process, with a hearing scheduled for Thursday. But as of late last week, there were still unresolved issues.

FDA reform bill criticized

FDA reform bill criticized

By Steven Ross Johnson  |  April 11, 2015

House Republicans are promoting a broad new bill supported by drugmakers and medical-device manufacturers that they say would make promising medications and devices available to the public faster and significantly reduce the costs associated with product development.

Hamburg to serve as IOM foreign secretary

Hamburg to serve as IOM foreign secretary

By Adam Rubenfire  |  April 06, 2015

The Institute of Medicine has tapped Dr. Margaret Hamburg, former commissioner of the U.S. Food and Drug Administration, to serve as its next foreign secretary.

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