“Breakthrough Therapy” Development Speed May Be Tempered By Manufacturing Hurdles
Executive Summary
Sponsors and FDA also will have to work through issues related to companion diagnostics to prevent treatments designated under the FDASIA’s new expedited development pathway from being delayed. Harmonization with foreign regulators is essential to making the pathway work, stakeholders say.
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FDA appears to be establishing new regulatory paradigm – albeit one that is not laid out in statute officially.