Try­ing to avoid a CRL? New FDA draft guid­ance talks ben­e­fit-risks on qual­i­ty as­sess­ments

As man­u­fac­tur­ing-re­lat­ed is­sues con­tin­ue to plague the bio­phar­ma in­dus­try and lead to dozens or more FDA re­jec­tions, or CRLs, each year, the agency on Mon­day re­leased new draft guid­ance spelling out how it as­sess­es qual­i­ty risks, sources of un­cer­tain­ty, and pos­si­ble mit­i­ga­tion strate­gies.

The FDA’s prod­uct qual­i­ty as­sess­ment, ac­cord­ing to the 12-page draft, de­ter­mines whether an ap­pli­cant’s prod­uct de­vel­op­ment stud­ies, man­u­fac­tur­ing process, and con­trol strat­e­gy will con­sis­tent­ly re­sult in a fin­ished drug or bi­o­log­ic of ac­cept­able qual­i­ty when man­u­fac­tured at the fa­cil­i­ties named in the ap­pli­ca­tion.

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