Author: ProEd Regulatory

ProEd Regulatory

Regulatory Policy Watch: Proposed Reforms to the Accelerated Approval Pathway
ByProEd Regulatory May 19, 2022May 19, 2022

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…

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ProEd Regulatory

Can You Predict Whether You Will Face an FDA Advisory Committee?
ByProEd Regulatory January 14, 2016January 15, 2016

The US Food and Drug Administration (FDA) review of drugs, although guided by broad standards, remains individualized. Each drug or drug class faces unique challenges during the FDA review phase – thus no two reviews are exactly the same. Each review division within the FDA has its own approach, and evaluations often differ among the…

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