Biopharma manufacturers call for clarity on FDA’s advanced designation guidance 

Phar­ma com­pa­nies are ex­press­ing fears that the FDA’s new ad­vanced man­u­fac­tur­ing tech des­ig­na­tion guid­ance could “bur­den” the agency, ac­cord­ing to com­ments re­cent­ly made pub­lic.

The 13-page guid­ance pub­lished in De­cem­ber out­lined ways to in­cor­po­rate ad­vanced man­u­fac­tur­ing tech­nol­o­gy (AMT) dur­ing the man­u­fac­tur­ing and de­vel­op­ment of drugs. Ac­cord­ing to the guid­ance, com­pa­nies will be giv­en pri­or­i­ty des­ig­na­tion by the FDA if they use AMT to im­prove drug qual­i­ty or to com­mer­cial­ly man­u­fac­ture drugs in short­age.

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