FDA officials, drug developers discuss how to streamline safety monitoring for biologics

FDA of­fi­cials, aca­d­e­m­ic re­searchers and drug de­vel­op­ers gath­ered at the FDA’s head­quar­ters on Mon­day to dis­cuss the land­scape for mon­i­tor­ing the safe­ty and ef­fi­ca­cy of bi­o­log­ic drugs.

The FDA, in col­lab­o­ra­tion with the Amer­i­can As­so­ci­a­tion of Phar­ma­ceu­ti­cal Sci­en­tists, held the day-long pub­lic work­shop in Sil­ver Spring, MD, to glean ways to tack­le what’s known as ther­a­peu­tic drug mon­i­tor­ing — a method used by clin­i­cians to track drug lev­els in a per­son’s blood­stream. The prac­tice is fre­quent­ly used to de­ter­mine op­ti­mal dos­es, es­pe­cial­ly for drugs that can be eas­i­ly un­der- or over-dosed.

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