United States: FDA Flexes Its New FDORA Muscles In Withdrawing An Accelerated Approval - Hyman, Phelps, & McNamara

Mondaq

08 Mar 2024 0 shares 1 views

Mondaq

Published 08 Mar 2024

On Friday, February 23, 2024, FDA announced its final decision to withdraw the approval of Pepaxto (melphalan flufenamide), which was approved...

United States: How To Run DMC? It's Tricky – FDA's New Draft Guidance Provides Updated Recommendations On How To Best Use Data Monitoring Committees In Clinical Trials - Hyman, Phelps, & McNamara

The trio of CDER, CBER, and CDRH released a new draft guidance titled "Use of Data Monitoring Committees in Clinical Trials" that..

Mondaq 15 Mar 2024

On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of..

Mondaq 13 Mar 2024