Lia DeGroot

FDA on Mon­day is­sued warn­ing let­ters to eight com­pa­nies for mar­ket­ing un­ap­proved treat­ments for eye con­di­tions. The eight com­pa­nies — Bo­iron, CVS Health, DR Vi­t­a­min

The FDA cleared up­dat­ed Covid-19 boost­er shots from Pfiz­er/BioN­Tech and Mod­er­na for the fall sea­son on Mon­day, paving the way for a roll­out in the

The FDA in­di­cat­ed that it will main­tain some pan­dem­ic-era flex­i­bil­i­ties in in­sti­tu­tion­al re­view board (IRB) as­sess­ments of ex­pand­ed ac­cess drugs for in­di­vid­ual pa­tients in im­me­di­ate­ly-in-ef­fect

Medicare ben­e­fi­cia­ries paid four times more for pre­scrip­tion drugs than their plan spon­sors did in 2021, ac­cord­ing to a Gov­ern­ment Ac­count­abil­i­ty Of­fice (GAO) re­port on

With key AD­HD med­ica­tions still in short­age, the FDA on Wednes­day ap­proved a gener­ic ver­sion of Take­da’s Vy­vanse, com­ing af­ter the name-brand drug’s patent ex­pired

An ap­peals court on Fri­day re­vived a law­suit that sev­er­al doc­tors filed against the FDA last year, al­leg­ing that the agency over­stepped its au­thor­i­ty in

FDA on Fri­day pub­lished draft guid­ance lay­ing out its ap­proach to post-warn­ing let­ter meet­ings for gener­ic drug­mak­ers, in­clud­ing the cri­te­ria for grant­i­ng the meet­ings and

Sens. Mag­gie Has­san (D-NH) and Tina Smith (D-MN) are ask­ing the three ma­jor in­sulin man­u­fac­tur­ers — Eli Lil­ly, No­vo Nordisk, and Sanofi — to pro­vide

Sen. Eliz­a­beth War­ren (D-MA) and Rep. Prami­la Jaya­pal (D-WA) are call­ing on the FDA to make re­forms to the Or­ange Book of gener­ic drug patents

The FDA pub­lished fi­nal guid­ance on Wednes­day on the use of re­al-world da­ta and re­al-world ev­i­dence in drug de­vel­op­ment to sup­port reg­u­la­to­ry de­ci­sion mak­ing. The