September 29, 2022 03:21 PM EDTUpdated 04:26 PM

FDA's advanced therapies office provides more clarity on gene therapy CMC considerations

Tyler Patchen

News Reporter

As the Office of Tissue and Advanced Therapies (OTAT) transforms into the Office of Therapeutic Products (OTP), with new user fee funds and “super office …

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FDA's advanced therapies office provides more clarity on gene therapy CMC considerations

Tyler Patchen

News Reporter

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FDA's ad­vanced ther­a­pies of­fice pro­vides more clar­i­ty on gene ther­a­py CMC con­sid­er­a­tions

Tyler Patchen

News Reporter

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

Sur­round­ed by AI bio gi­ants, tiny start­up Nabla Bio makes de no­vo an­ti­bod­ies look more like drugs

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

FDA's advanced therapies office provides more clarity on gene therapy CMC considerations

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

Surrounded by AI bio giants, tiny startup Nabla Bio makes de novo antibodies look more like drugs

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