Annie Kennedy's Blog – February 2016 Archive (1)

Advancing Targeted Therapies for Rare Diseases Act Goes Before HELP Committee

For nearly two years, PPMD has been working with Congressional champions and industry partners to help lead an effort to streamline the regulatory pathways and review processes for targeted therapeutics (which would include such things as ‘follow on exons’) by clarifying the FDA’s existing authority to leverage data previously used in the approval of a targeted product when approving a new therapy. These efforts have yielded a provision in the House of Representatives…


Added by Annie Kennedy on February 9, 2016 at 3:36pm — 8 Comments

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