FDA’s Marks, Woodcock talk regulatory flexibility for new rare disease drugs

The FDA’s top bi­o­log­ics chief and a for­mer deputy com­mis­sion­er on Tues­day dis­cussed the need for reg­u­la­to­ry flex­i­bil­i­ty for rare dis­ease ther­a­pies and un­der­scored the need to bol­ster gene ther­a­py man­u­fac­tur­ing.

Pe­ter Marks, the FDA’s bi­o­log­ics cen­ter di­rec­tor, and Janet Wood­cock, for­mer FDA deputy com­mis­sion­er who re­tired ear­li­er this year, dis­cussed how the agency should be able to bal­ance fol­low­ing reg­u­la­tions with ex­er­cis­ing some flex­i­bil­i­ty for rare dis­eases.

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