Real-World Data: Sponsors Should Ensure US FDA Access To Patient-Level Data Upon Submission

Informed consent from patients, or institutional review board waivers, are needed to allow bioresearch monitoring inspectors to review source records in a timely fashion without delaying a user fee date, FDA’s Cheryl Grandinetti tells an international good clinical practices workshop.

Cherries
FDA BIMO inspectors want to make sure sponsors aren't cherry-picking favorable real-world data. • Source: Alamy

Sponsors who submit a drug application containing real-world data should ensure that certain measures have been taken ahead of time so that US Food and Drug Administration bioresearch monitoring (BIMO) inspectors can timely review RWD source records without delaying a product’s user fee date.

Prior to data extraction from the RWD source, sponsors should obtain signed informed consent from patients, or institutional review board...

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’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.

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.

Animal Testing Alternatives: US Pharmacopeia On Its Testing Transition

 

In this second of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet which animal testing models have alternative options and highlights where further investment and research is needed to develop appropriate alternatives.