As part of ef­forts to pre­pare for the con­tin­ued rise in da­ta-rich ap­pli­ca­tions and to help fill the gap sep­a­rat­ing sci­en­tif­ic ad­vances and new ther­a­pies, the FDA on Wednes­day un­veiled its Tech­nol­o­gy Mod­ern­iza­tion Ac­tion Plan (TMAP).

Near-term mod­ern­iza­tion in com­put­er hard­ware and soft­ware tech­nolo­gies are the fo­cus of the FDA’s TMAP, which of­fers a broad overview of how the agency needs to adapt. For in­stance, the TMAP re­port notes that the FDA will need to have a tech­ni­cal in­fra­struc­ture that can ac­cept, eval­u­ate and an­a­lyze nov­el sources of da­ta (e.g., re­al-world da­ta) and ap­ply that da­ta to reg­u­la­to­ry de­ci­sion mak­ing over the next sev­er­al years.

“FDA’s ac­tion plan has three el­e­ments: (1) mod­ern­iza­tion of FDA’s tech­ni­cal in­fra­struc­ture; (2) en­hanced ca­pa­bil­i­ties at FDA to de­vel­op tech­nol­o­gy prod­ucts to sup­port its reg­u­la­to­ry mis­sion; and (3) com­mu­ni­ca­tion and col­lab­o­ra­tion be­tween FDA and stake­hold­ers, in­clud­ing the tech­nol­o­gy in­dus­try and oth­er gov­ern­ment agen­cies, to dri­ve tech­no­log­i­cal progress that is in­ter­op­er­a­ble across the sys­tem and de­liv­ers val­ue to con­sumers and pa­tients,” the re­port says.

Over­seen by the FDA’s Of­fice of In­for­ma­tion Man­age­ment and Tech­nol­o­gy (OIMT), in the com­ing months the FDA will en­gage with stake­hold­ers to de­vel­op a strat­e­gy and un­der­stand­ing of com­mon pri­or­i­ties for the agency’s ap­proach to da­ta.

“Is­sues to ad­dress in this con­text will in­clude: How FDA will en­sure that reg­u­la­to­ry de­ci­sions at the Agency con­tin­ue to be in­formed by high-qual­i­ty da­ta; How FDA will pro­mote ef­fi­cient da­ta use and da­ta stew­ard­ship across the Agency; How FDA will con­tin­ue its on­go­ing com­mit­ment to a high­ly se­cure da­ta and IT en­vi­ron­ment,” the re­port notes.

The FDA al­so ex­plains how it will start with “small pi­lot use case projects” to link reg­u­la­to­ry ex­per­tise with tech­nol­o­gy know-how by bring­ing FDA re­view­ers and tech­nol­o­gists to­geth­er to tar­get prob­lems and op­por­tu­ni­ties that will ad­vance mod­ern­iza­tion ef­forts.

“These so­lu­tions high­light what is pos­si­ble with­in FDA’s cur­rent en­vi­ron­ment. Ex­am­ples for con­sid­er­a­tion in­clude Pre­ci­sionF­DA, 7- and 15-day safe­ty re­port­ing for In­ves­ti­ga­tion­al New Drug (IND) ap­pli­ca­tions, and up­dat­ing the PRE­DICT mod­el with ma­chine learn­ing,” the re­port notes.

The agency will al­so look to build new tech­nolo­gies to en­able re­al-time FDA op­er­a­tional man­age­ment dash­boards, a col­lab­o­ra­tive project with Of­fice of the Na­tion­al Co­or­di­na­tor for Health In­for­ma­tion Tech­nol­o­gy on the “life of a da­ta el­e­ment” and tech­no­log­i­cal so­lu­tions for the FDA’s im­port op­er­a­tions.

Plan

RAPS: First pub­lished in Reg­u­la­to­ry Fo­cus™ by the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety, the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care prod­ucts. Click here for more in­for­ma­tion.
 

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