How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Re­al-world da­ta are messy. There can be dif­fer­ences in the stan­dards used to col­lect dif­fer­ent types of da­ta, dif­fer­ences in ter­mi­nolo­gies and cu­ra­tion strate­gies, and even in the way da­ta are ex­changed.

While ac­knowl­edg­ing this some­what con­trolled chaos, the FDA is now ex­plain­ing how bio­phar­ma com­pa­nies can sub­mit study da­ta de­rived from re­al-world da­ta (RWD) sources in ap­plic­a­ble reg­u­la­to­ry sub­mis­sions, in­clud­ing new drug in­di­ca­tions.

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