En­sur­ing con­sis­ten­cy in prod­uct qual­i­ty: How FDA's re­quests for more in­fo will be for­mal­ized

Mak­ing sure a phar­ma spon­sor and the FDA are on the same page when it comes to a new drug de­vel­op­ment pro­gram, par­tic­u­lar­ly around man­u­fac­tur­ing, can be cru­cial to en­sur­ing the drug gets a fair shake as the re­view process plays out.

One as­pect of this di­a­logue is the agency may is­sue an in­for­ma­tion re­quest (IR) via let­ter, email or fax — where FDA seeks a clar­i­fi­ca­tion to help its re­view.

But these IRs from CDER and CBER must be stan­dard­ized, and ad­here close­ly to what’s known as “Four-Part Har­mo­ny,” which is where re­view­ers are ex­pect­ed to com­mu­ni­cate to spon­sors: “(1) what was pro­vid­ed, (2) what is the is­sue or de­fi­cien­cy, (3) what is need­ed, and (4) why it is need­ed.”

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