Real-Word Evidence Generation System Will Be A Priority For Califf As FDA Commissioner

At his Senate confirmation hearing, Robert Califf said he wants to establish a system, built on electronic medical records, that can be used to more quickly confirm the benefits and risks of accelerated approval drugs.

Robert Califf at Senate  HELP confirmation hearing 14 December 2021 (screenshot)
Robert Califf offered thoughts on how to speed the confirmation of accelerated approvals during his own confirmation hearing. • Source: Screenshot

Establishing the framework for a systematic approach to real-world evidence generation that would allow for quicker confirmation of the benefits and risks of accelerated approval drugs, among other uses, will be a key priority for Robert Califf if confirmed as the next US Food and Drug Administration commissioner.

During his 14 December confirmation hearing before the Senate Health, Education, Labor and Pensions Committee, Califf said an evidence generation...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Real-World Evidence

EMA Sets New Priorities As Number Of RWE Studies Climbs 48%

 

Real-world data studies conducted by the European Medicines Agency increased by 48% according to its latest report on the topic, prompting the agency to consider how it can better integrate this type of evidence into regulatory decision-making.

AI Will Bolster, Not Squelch, Patient Voice In Clinical Research, US FDA Says

 
• By 

Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.

Post-Approval, Real-Time Monitoring Will Help Approval Standards, US FDA’s Makary Says

 
• By 

The FDA will use electronic health records to “get eyes” on drugs immediately after approval, Commissioner Martin Makary told the DIA 2025 Global Annual Meeting. He also wants to reduce development time with better communication and new approval pathways.

US FDA’s Prasad: ‘We Will Always Embrace Surrogate Endpoints’

 

The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.

More from Clinical Trials

UK HRA Sets Targets For Digital Overhaul, Trial Transparency And Trust

 
• By 

The UK Health Research Authority’s latest three-year strategy sets ambitious targets to make research more transparent. One World Health Organization official believes the authority can go further by setting equally high standards for the timely reporting of clinical trial results.

Otsuka/Lundbeck’s Rexulti PTSD Claim Will Test US FDA AdComm’s Supportive Evidence Flexibility

 

Rexulti’s post-traumatic stress disorder sNDA tries to make up for a failed Phase III study by placing a Phase II study into a key evidentiary role, raising questions for the July 18 advisory committee meeting about assessing discordant results and post-hoc analyses.

UK’s Plan To Become World’s Third Top Life Sciences Economy Falls Short, Says ABPI

 

The Association of the British Pharmaceutical Industry says that while the government’s newly published Life Sciences Sector Plan includes many positive commitments, they are not enough.