Lia DeGroot

The state of Flori­da on Mon­day again took a swing at the FDA, al­leg­ing in an amend­ed law­suit filed in a Flori­da dis­trict court that

FDA bi­o­log­ics cen­ter di­rec­tor Pe­ter Marks said the agency plans to en­cour­age spon­sors to use the ac­cel­er­at­ed ap­proval path­way, par­tic­u­lar­ly for rare dis­ease treat­ments, as

Am­gen and Hori­zon Ther­a­peu­tics filed a memo last week call­ing on an Illi­nois fed­er­al judge to up­hold the com­pa­nies’ ar­gu­ments against the con­sti­tu­tion­al­i­ty of the

No­vo Nordisk has spent the sum­mer build­ing out its lob­by­ing team on K Street as part of its ef­forts to get Medicare to cov­er obe­si­ty

The FDA on Thurs­day pub­lished draft guid­ance on con­sid­er­a­tions for post­mar­ket stud­ies on pop­u­la­tions that were un­der­rep­re­sent­ed in pre­mar­ket tri­als. The agency tells spon­sors to

The FDA is con­tin­u­ing to low­er the bar of its ap­proval stan­dards for nov­el drug ap­pli­ca­tions, ac­cord­ing to a new analy­sis of ev­i­dence on ap­provals

The De­part­ment of De­fense has se­lect­ed the drug qual­i­ty test­ing com­pa­ny Val­isure to car­ry out qual­i­ty rat­ings for drugs sup­plied to the de­part­ment as law­mak­ers

Hos­pi­tal groups are ask­ing Con­gress to do a bet­ter job of over­see­ing the 340B drug dis­count pro­gram, and they are call­ing on law­mak­ers to step

Two weeks af­ter a tor­na­do dam­aged a ware­house at a Pfiz­er plant in North Car­oli­na, the com­pa­ny is plac­ing 12 drugs on emer­gency or­der to

Af­ter the FDA this past spring laid out its ap­proach to de­cen­tral­ized clin­i­cal tri­als, stake­hold­ers are large­ly wel­com­ing the guid­ance, but are ask­ing the agency