Regulatory Policy Watch: Proposed Reforms to the Accelerated Approval Pathway

ByProEd Regulatory

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…

Pitfalls of Accelerated Approval: What Happens When Confirmatory Trials Fail?

ByAngela Corona

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 on the basis of surrogate endpoints that are…