FDA+ channel feed

Organon shelves con­tra­cep­tive with 'nat­u­ral' es­tro­gen

Last year
Pharma

Stake­hold­ers brace for bumps in rare pe­di­atric dis­ease PRV reau­tho­riza­tion

Last year
Pharma

Take­da wins long-await­ed US ap­proval for first oral drug for eosinophilic esophagi­tis

Last year
Pharma

FDA ad­dress­es ex­pand­ed use of da­ta mon­i­tor­ing com­mit­tees in draft guid­ance

Last year
Pharma

FDA fi­nal­izes rule on us­ing mas­ter files in bi­o­log­ics ap­pli­ca­tions

Last year
Pharma

US and EU reg­u­la­tors be­gin of­fer­ing par­al­lel sci­en­tif­ic ad­vice to gener­ic drug­mak­ers

Last year

Af­ter 'mis­lead­ing' in­for­ma­tion de­lays FDA in­spec­tion, Chi­nese API man­u­fac­tur­er hit with an OAI

Last year
Manufacturing

House pass­es ban on use of QALYs in fed­er­al health pro­grams

Last year
Pharma

As­traZeneca CEO calls open­ing IRA drug price of­fer 'rel­a­tive­ly en­cour­ag­ing' in first char­ac­ter­i­za­tion of talks

Last year
Pharma

Catal­ent’s In­di­ana site clos­es out three Form 483s in past two years

Last year
Manufacturing

EMA seeks to ease the reg­u­la­to­ry bur­den on biosim­i­lar de­vel­op­ers, fol­low­ing push by FDA

Last year

House com­mit­tee ad­vances an­oth­er PBM re­form bill that would ban spread pric­ing

Last year
Pharma

Law­mak­ers hold FDA for­eign in­spec­tion prac­tices un­der mi­cro­scope at hear­ing with­out agency at­ten­dance

Last year
Pharma
Manufacturing

Be­hind gener­ic drug short­ages, House com­mit­tee points to lack­lus­ter man­u­fac­tur­ing and high prices

Last year
Manufacturing

Will an up­com­ing Sen­ate hear­ing help low­er drug prices? It de­pends who you ask

Last year
Pharma

Ver­tex un­veils cys­tic fi­bro­sis da­ta, talks of us­ing pri­or­i­ty re­view vouch­er

Last year
Pharma

Van­da takes is­sue with FDA's re­lay of de­fi­cien­cies for new Het­lioz in­di­ca­tion

Last year
Pharma

Mak­ers of block­buster weight loss drugs are us­ing 'patent thick­et­s' to pro­tect prod­ucts, Har­vard study claims

Last year
Pharma

FDA to mod­ern­ize drug sur­veil­lance in­ter­nal­ly with use of AI

Last year
AI

Amer­i­can Bar As­so­ci­a­tion says low­er court was 'ill-equipped' to re­strict abor­tion pill use

Last year
Pharma
Law

Draft 340B re­forms in­clude user fees, clar­i­ty around con­tract phar­ma­cies

Last year
Pharma
Law

For­mer FDA com­mis­sion­ers urge SCO­TUS to pre­serve agency’s reg­u­la­tions of abor­tion pill

Last year
Pharma
Law

AGC Bi­o­log­ics hit with 483 for poor dis­crep­an­cy in­ves­ti­ga­tion prac­tices, qual­i­ty con­trol is­sues at Wash­ing­ton site

Last year
Pharma
Manufacturing

'Sys­temic' changes com­ing to ad­vi­so­ry com­mit­tee process, FDA com­mis­sion­er says

Last year
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