January 18, 2023 12:59 PM EST

FDA+ roundup: Lessons learned from two quality ratings pilots; Expanded FDA collab with organ-on-a-chip company

Zachary Brennan

Senior Editor

The FDA since at least 2019 has been fiddling with the idea of adding drug/active pharmaceutical ingredient (API) manufacturing quality ratings or scores as part …

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FDA+ roundup: Lessons learned from two quality ratings pilots; Expanded FDA collab with organ-on-a-chip company

Zachary Brennan

Senior Editor

Sign up to read this article for free.

Among pharma CEOs, the IRA now and the IRA later get very different reactions

Bristol Myers restarts radiopharmaceutical Phase 3 trial, but delays readout by one year

Andrew Left, short seller who campaigned against Valeant, is accused of fraud by SEC

Updated: With cost-cutting underway, Bristol Myers raises guidance, touts Phase 3 win and scraps another

Compounded weight loss drugs have resulted in misdosing, hospitalizations, FDA warns

Critical Junctures in Gene Therapy Clinical Material Manufacturing: Where Do I Start? And Will It Work?

FDA+ roundup: Lessons learned from two qual­i­ty rat­ings pi­lots; Ex­pand­ed FDA col­lab with or­gan-on-a-chip com­pa­ny

Zachary Brennan

Senior Editor

Sign up to read this article for free.

Among phar­ma CEOs, the IRA now and the IRA lat­er get very dif­fer­ent re­ac­tions

Bris­tol My­ers restarts ra­dio­phar­ma­ceu­ti­cal Phase 3 tri­al, but de­lays read­out by one year

An­drew Left, short sell­er who cam­paigned against Valeant, is ac­cused of fraud by SEC

Up­dat­ed: With cost-cut­ting un­der­way, Bris­tol My­ers rais­es guid­ance, touts Phase 3 win and scraps an­oth­er

Com­pound­ed weight loss drugs have re­sult­ed in mis­dos­ing, hos­pi­tal­iza­tions, FDA warns

Crit­i­cal Junc­tures in Gene Ther­a­py Clin­i­cal Ma­te­r­i­al Man­u­fac­tur­ing: Where Do I Start? And Will It Work?

FDA+ roundup: Lessons learned from two quality ratings pilots; Expanded FDA collab with organ-on-a-chip company

Among pharma CEOs, the IRA now and the IRA later get very different reactions

Bristol Myers restarts radiopharmaceutical Phase 3 trial, but delays readout by one year

Andrew Left, short seller who campaigned against Valeant, is accused of fraud by SEC

Updated: With cost-cutting underway, Bristol Myers raises guidance, touts Phase 3 win and scraps another

Compounded weight loss drugs have resulted in misdosing, hospitalizations, FDA warns

Critical Junctures in Gene Therapy Clinical Material Manufacturing: Where Do I Start? And Will It Work?