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Regulatory Policy Watch: The FDA Is Taking Accelerated Approval Pathway Reforms Into Their Own Hands

On September 30, 2022, President Biden signed into law the reauthorization of the Prescription Drug User Fee Act (PDUFA VII), which will be in place for the next 5 years. Despite extensive bipartisan efforts to include reforms of the accelerated approval (AA) pathway as so-called “policy riders” in the bill, ultimately a “practically clean” version…

Regulatory Policy Watch: Proposed Reforms to the Accelerated Approval Pathway

By Jackie Orabone, PhD and Angela Corona, PhD The accelerated approval (AA) pathway was introduced in 1992 (in response to the AIDS epidemic) to shorten the FDA approval process for drugs to treat serious or life-threatening diseases or rare diseases where there is a high unmet medical need. AA allows for drugs to be approved…