Drug Price Hikes, Shortages Follow FDA Crackdown On Unapproved Drugs
Executive Summary
Study finds unintended consequences of FDA initiative requiring manufacturers of unapproved drugs to obtain approval or remove them from the market but FDA says study does not consider broad impact of the initiative.
You may also be interested in...
US FDA’s Unapproved Drugs Initiative Comes Back To Life, With New Enforcement Guidance On Its Way
Longstanding compliance policy program aimed at getting marketed but unapproved drugs through the NDA/ANDA pathway is reinstated because its termination by the Trump Administration was ‘legally and factually inaccurate’; some experts want FDA to consider program’s impact on drug pricing as it re-establishes the initiative.
US FDA’s Unapproved Drug Initiative Nixed, But Without Agency Buy-In Demise May Be Short-Lived
Trump administration effort to reduce drug prices by curtailing agency program requiring new approvals for some old products undermines FDA’s role in policing the safety of prescription drugs, experts say.
Compounding Draft Guidance May End Par's Suit Against US FDA
Par says FDA shouldn't have authorized a compounded version of Vasostrict, but parties have asked court to wait until March, when a guidance is expected that may resolve the company's concerns.