1. Pink Sheet

Time To Simplify US FDA’s Expedited Pathways? It Won’t Be Simple

 
• By Michael McCaughan

Oncology center director Pazdur thinks it is time to streamline the expedited pathways for drug development in the US. Focusing on the goals, rather than the paperwork, is a good idea – but is easier said than done.

• Source: Alamy

US Food & Drug Administration Oncology Center of Excellence Director Richard Pazdur thinks the time is right to simplify the number of “expedited” pathways that FDA and drug sponsors use as part of the regulatory process.

Pazdur has emphasized that point as part of an initiative launched by Friends of Cancer Research last fall to build on the success of the “Breakthrough Therapy” designation process launched...

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