Gen­er­al­ly ac­cept­ed sci­en­tif­ic knowl­edge: FDA ex­plains how it ap­plies to non­clin­i­cal da­ta in drug apps

Fol­low­ing an “in­creas­ing num­ber of ques­tions” on the ex­tent to which gen­er­al­ly ac­cept­ed sci­en­tif­ic knowl­edge (GASK) may be re­lied on by the FDA as part of ap­proval de­ci­sions, the agency to­day put out a new, 6-page draft guid­ance on the top­ic of GASK, with ex­am­ples of when it might be used ap­pro­pri­ate­ly.

In cer­tain cas­es where GASK ap­plies to an NDA or BLA, FDA says it may be un­nec­es­sary for a spon­sor to con­duct cer­tain non­clin­i­cal stud­ies, which saves them time, and the FDA notes, “de­creas­es a drug’s de­vel­op­ment costs.” The draft de­fines GASK as “med­ical or sci­en­tif­ic in­for­ma­tion that is gen­er­al­ly ac­cept­ed by ex­perts qual­i­fied by sci­en­tif­ic train­ing and ex­pe­ri­ence in the rel­e­vant field,” and the agency points to two spe­cif­ic ex­am­ples of where GASK was ac­tu­al­ly used to meet rel­e­vant ap­proval re­quire­ments.

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Venture & Research Associate

Alexandria Real Estate Equities

San Francisco, CA, USA