JD Supra

The Commercial Potential – and Practical Challenges – of Marketing OTC Drugs With ‘Additional Conditions for Nonprescription Use’

The Food and Drug Administration’s (FDA or Agency) final rule on Additional Conditions for Nonprescription Use (ACNU) paves the way for some drugs that are currently available only with a prescription ...
JD Supra

FDA Drug Inspections Post–Workforce Reductions: Potential Implications and Practical Steps Forward

The US Food and Drug Administration (FDA) is confronted with significant challenges in its inspection processes due to recent layoffs. Among other effects, the latest reduction in force of full-time ...
CNBC

FDA to consider drug affordability when granting new vouchers to speed up approvals, Makary says

The Food and Drug Administration will consider drug affordability when granting companies new vouchers that speed up approvals of some treatments, the agency's Commissioner Marty Makary told CNBC. The ...
STAT

The Trump administration is turning drug review into make-a-deal

Carpenter is professor of government at Harvard. Hwang is a regulatory policy researcher at Brigham and Women’s Hospital. Kesselheim is professor of medicine at Brigham and Women’s Hospital and ...