Over the last several decades, the US Food and Drug Administration’s (FDA) accelerated approval program has largely been working as it was designed to, with about half the products using the pathway ...

The uncertainty of benefit at the time of accelerated approval may result in substantial spending on products that are ultimately proven ineffective. The heightened scrutiny on accelerated approvals ...

For driven first-year RIT students like Lauren Reger and Palak Wadhwa, getting a jump on studying and conducting research, all while steadily moving on the path toward a graduate degree, was an ...

The Food and Drug Administration’s accelerated approval program aims to speed “approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint” of overall ...

On Dec. 6, 2024, the FDA released draft guidance, marking a significant development in the regulatory framework for therapies approved under the Accelerated Approval Program. The 22-page guidance ...

Since the U.S. Food and Drug Administration established its accelerated approval pathway for drugs in 1992, 112 of the 253 drugs authorized have not been confirmed as clinically effective, an ...

Accelerated approvals for cancer drugs is a good idea in theory. This US Food and Drug Administration (FDA) pathway allows promising new cancer agents to reach the market, and patients, sooner. But ...

Hope College students majoring in communication can take a fast track to a master’s degree thanks to a new partnership between the college and Western Michigan University. The college and university ...