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DTC For Accelerated Approval Drugs: US FDA Is Taking Another Look At Disclosure On Websites

 
• By Brenda Sandburg

Study will assess responses of cancer survivors and caregivers to disclosures that a drug received accelerated approval. FDA analysis found that 73% of 26 accelerated approval drugs cited approval pathway on product websites.

accelerated
FDA to assess consumer reaction to disclosure of drug's accelerated approval in product website • Source: Alamy

The US Food and Drug Administration plans to conduct another study to determine whether disclosure that a product received accelerated approval impacts consumer perceptions of the drug. The research project comes as accelerated approval is in the public spotlight following the FDA’s approval of Biogen, Inc. and Eisai Co., Ltd.’s ’s Alzheimer’s disease drug Aduhelm (aducanumab) via this pathway.

The proposed study by FDA’s Office of Prescription Drug Promotion is specifically evaluating the responses of cancer survivors and their...

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More from Approvals

US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 
• By Bridget Silverman

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Autolus’s Aucatzyl And GSK’s Blenrep Among 10 New Drugs To Get EMA Nod

 
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The European Medicines Agency has OKd 10 new medicines for EU-wide approval, including a CAR-T therapy for treating acute lymphoblastic leukemia. Two drugs were, however, rejected.

EU Authorization Before US? Biologics Manufacturing Is Likely To Blame

 
• By Bridget Silverman

In the infrequent cases when EU authorization precedes US FDA approvals of new products, biologics manufacturing issues are usually to blame, a Pink Sheet analysis found.

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New EU Approvals

 
• By Neena Brizmohun

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.

US FDA Meeting Drought Ends … With A Vengeance

 
• By Michael McCaughan

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EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.