Regulatory histories of recently withdrawn ovarian cancer treatment indications of 3 PARP inhibitors in the US and Europe: lessons for the accelerated approval pathway

• Príomhchruthaitheoirí: Mahnum Shahzad (Údar), Huseyin Naci (Údar), Katharine M. Esselen (Údar), Joseph A. Dottino (Údar), Anita K. Wagner (Údar)
• Formáid: LEABHAR
• Foilsithe / Cruthaithe: Taylor & Francis Group, 2024-12-01T00:00:00Z.
• Ábhair: article
• Rochtain ar líne: Connect to this object online.

Background Withdrawals of drug indications may reveal potential inadequacies in the regulatory approval processes of new drugs. Understanding potential weaknesses of the regulatory approval process is paramount given the increasing use of expedited pathways. In this paper, we focus on three poly-ADP...