FDA rolls out new draft guid­ance on ad­vanced man­u­fac­tur­ing tech

The FDA un­veiled on Tues­day a draft guid­ance for phar­ma­ceu­ti­cal com­pa­nies who want to use “ad­vanced man­u­fac­tur­ing tech­nol­o­gy” (ATM) in drug de­vel­op­ment in or­der to short­en and im­prove sup­ply chains in the US.

ATM can be de­fined as a “nov­el” tech­nol­o­gy not al­ready used dur­ing phar­ma­ceu­ti­cal drug man­u­fac­tur­ing for small mol­e­cule drugs or bi­o­log­ics that aims to make process­es more ef­fi­cient. The agency en­cour­ages the use of tech­nol­o­gy to im­prove the man­u­fac­tur­ing process of med­i­cines, stat­ing it can im­prove the qual­i­ty, re­li­a­bil­i­ty and ro­bust­ness of sup­ply, as well as re­duce drug de­vel­op­ment time.

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