Real-World Evidence Could Speed Development Of Drugs Offering Incremental Improvements
Executive Summary
US FDA Commissioner Gottlieb says common diseases need new treatments and argues streamlining trials may pique industry interest.
You may also be interested in...
US Throws Drug Pricing Weight Around, But Still Depends On Pharma Decisions
US may have substantial drug purchasing muscle, as evident in latest CMS proposal to reform Medicare Part B, but still needs pharma to force prices down.
Drug/Software Combo Platform Coming Soon To US FDA, Gottlieb Says
Under new platform, drugs could soon be approved with accompanying software applications that could monitor adverse events or patient compliance without a separate premarket device review.
US FDA Amps Up "Name And Shame" Approach To Thwart Anti-Generic Tactics
New draft guidance says citizen petition abuses will be referred to FTC and publicly called out as attempts to delay ANDA approvals.