Contact

Comments on Reauthorization of the Prescription Drug User Fee Act FY2028-2032 (PDUFA VIII)

Martin MJ, Hwang TJ, Tibau A, Rand LZ, Tanveer S, Kesselheim AS - Food and Drug Administration (FDA)

  • Policy Interactions
| October 2026
  • Regulation and Clinical Evidence

Summary:

VIEW SOURCE
An icon of a bill representing government policy.

LEARN MORE

BROWSE POLICY INTERACTIONS

Recent Work from PORTAL

Talk bubble graphics representing commentary and opinion.

How Congress Can Fix Expert Advisory Committees

Daval CJR, Kesselheim AS - STAT

  • Commentary & Opinion
| October 2026
  • Regulation and Clinical Evidence
View Source
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International Regulatory Status and Reimbursement Recommendations of Haematological Malignancy Drugs Withdrawn from the FDA Accelerated Approval Pathway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

  • Research Publications
| October 2026
  • Price, Value, and Access
  • Regulation and Clinical Evidence
View Source
Talk bubble graphics representing commentary and opinion.

The Impact of Semantics in Medicines Regulation

Costa E, Kesselheim AS - Journal of Law, Medicine, & Ethics

  • Commentary & Opinion
| October 2026
  • Innovation Incentives and Competition
  • Regulation and Clinical Evidence
View Source
VIEW MORE

Program On Regulation, Therapeutics, And Law (PORTAL)
Division of Pharmacoepidemiology and Pharmacoeconomics
Brigham and Women's Hospital • Harvard Medical School
41 Avenue Louis Pasteur, Suite 0B17, Boston, MA 02115

©2026 Program On Regulation, Therapeutics, And Law (PORTAL). All rights reserved.