New approval paths needed: report

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The Pew Charitable Trusts, Biotechnology Industry Organization (BIO), GlaxoSmithKline, and Pharmaceutical Research and Manufacturers of America (PhRMA) are voicing basic support for FDA's efforts to develop an alternative approval pathway for certain drugs intended to address unmet medical needs.

In comments to FDA, Pew reported results from a Jan. 31 meeting among stakeholders that explored the feasibility of such an alternate approval pathway. All panelists agreed on the urgent need for new antibiotics. The Pew report says that questions remaining from a business perspective include how “unmet need” would be defined and what evidence would be required for agency approval.

PhRMA says it is ready to continue to work with FDA and other stakeholders toward establishing an appropriate and targeted regulatory approach, but adds that FDA should first turn its attention to issuing science-based guidance related to clinical trials for antibiotics and the pathogen-focused development of antibiotics.
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