Using Trademarks to Ensure Completion of Postapproval Trials

Hwang CS, Tu SS - JAMA Health Forum

  • Innovation Incentives and Competition
  • Regulation and Clinical Evidence

Summary:

The FDA should use trademarks to ensure the timely completion of postapproval confirmatory trials for drugs granted accelerated approval . Manufacturer use of a drug’s trademarked brand or generic name should be restricted until trials confirm clinical benefit, instead requiring investigational names in promotional materials to communicate the drug’s clinical uncertainty.

VIEW SOURCE

Recent Work from PORTAL

Talk bubble graphics representing commentary and opinion.

How Congress Can Fix Expert Advisory Committees

Daval CJR, Kesselheim AS - STAT

  • Regulation and Clinical Evidence
Simple graphic of magnifying glass examining papers to signify reviewing research publications.

International Regulatory Status and Reimbursement Recommendations of Haematological Malignancy Drugs Withdrawn from the FDA Accelerated Approval Pathway

Mulsant SS, Kesselheim AS, Naci H - Journal of Cancer Policy

  • Price, Value, and Access
  • Regulation and Clinical Evidence
An icon of a bill representing government policy.

Comments on FDA Discussion Paper, “Considerations for the Regulation of Generative AI-Enabled Medical Devices”

Jaiswal N, Gorijavolu R, Thomas S, Hwang TJ, Celi LA, Kesselheim AS - Food and Drug Administration (FDA)

  • Regulation and Clinical Evidence