4:17 PM
Sep 12, 2018
 |  BC Extra  |  Politics & Policy

Proposal seeks FDA center for rare diseases

An FDA Rare Disease Center of Excellence (COE) could bring greater consistency and efficiency to regulatory review for rare disease products, according to a proposal from Hyman, Phelps & McNamara's Frank Sasinowski and James Valentine.

Sasinowski is a director and Valentine is an associate at Hyman, Phelps & McNamara, a firm specializing in FDA law.

The co-authors envision a Rare Disease COE with a similar...

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