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Industry Wants More Transparency From Agency On REMS Determinations

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SAN DIEGO - Industry is hoping an upcoming Risk Evaluation and Mitigation Strategy guidance document will outline a more transparent process regarding the FDA's REMS decisions

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Priority Review's Luster Dims In "Safety First Era" But Retains Value - Parexel

Sponsors of the most innovative new drugs should not be deterred by the apparent reversals of fortune for new molecular entities with priority review status in the last year, the consulting firm Parexel concludes in a new report

Priority Review's Luster Dims In "Safety First Era" But Retains Value - Parexel

Sponsors of the most innovative new drugs should not be deterred by the apparent reversals of fortune for new molecular entities with priority review status in the last year, the consulting firm Parexel concludes in a new report

Priority Review's Luster Dims In "Safety First Era" But Retains Value - Parexel

Sponsors of the most innovative new drugs should not be deterred by the apparent reversals of fortune in the last year for NDAs with priority review status, the consulting firm Parexel concludes in a new report.

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