December 12, 2018 06:46 AM EST

FDA rolls out expectations for a looming regulatory shift for insulin and other biologics

Zachary Brennan

Senior Editor

Certain biologics will be removed from the FDA’s Orange Book on 23 March 2020 and included in the Purple Book, and all subsequent follow-on applicants …

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FDA rolls out expectations for a looming regulatory shift for insulin and other biologics

Zachary Brennan

Senior Editor

Sign up to read this article for free.

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FDA rolls out ex­pec­ta­tions for a loom­ing reg­u­la­to­ry shift for in­sulin and oth­er bi­o­log­ics

Zachary Brennan

Senior Editor

Sign up to read this article for free.

Trump names Johns Hop­kins re­searcher Mar­ty Makary to lead the FDA; al­so names CDC, Sur­geon Gen­er­al picks

FDA ap­proves Bridge­Bio's heart dis­ease drug, set­ting up com­pe­ti­tion with Pfiz­er, Al­ny­lam

Drug or bi­o­log­ic? An Eli Lil­ly law­suit could im­pact weight loss drug com­pounders

Lil­ly's board un­der­goes more changes; Mer­ck strat­e­gy chief joins Roger Perl­mut­ter at Eikon

Pa­tient dies in Neu­ro­gene's Rett syn­drome study

Are pro­grams with com­pound­ed GLP-1s safe for your pop­u­la­tion?

FDA rolls out expectations for a looming regulatory shift for insulin and other biologics

Trump names Johns Hopkins researcher Marty Makary to lead the FDA; also names CDC, Surgeon General picks

FDA approves BridgeBio's heart disease drug, setting up competition with Pfizer, Alnylam

Drug or biologic? An Eli Lilly lawsuit could impact weight loss drug compounders

Lilly's board undergoes more changes; Merck strategy chief joins Roger Perlmutter at Eikon

Patient dies in Neurogene's Rett syndrome study

Are programs with compounded GLP-1s safe for your population?