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Real-World Evidence: Replication of Controlled Trials Expected To Fail Sometimes, US FDA Says

 
• By Nielsen Hobbs

Agency study deliberately not weighting RWE populations the same as RCTs it aims to duplicate. "We learn the most when we don't replicate," Harvard Medical School's Jessica Franklin tells the DIA annual meeting.

SAN DIEGO – The US Food and Drug Administration expects that its study to reproduce the results of randomized controlled trials using real-world evidence will fail to replicate in some instances – a result that could drive a better understanding of how to use claims and other real-world data.

Asked during a 25 June session of the DIA annual meeting, Center for Drug Evaluation and Research's David Martin acknowledged...

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More from Post-Marketing Regulation & Studies

EMA Touts Faster Global Post-Approval Changes Via Regulatory Reliance

 
• By Eliza Slawther

The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.

Novavax’s COVID-19 Vaccine Label Narrowed After Political Officials Intervened

 
• By Sarah Karlin-Smith

The label that Novavax's COVID-19 vaccine was slated to receive before political officials held up the approval was broader than was granted 16 May.

Opioid Safety: US FDA Hears Mixed Messages On Adding Posmarketing Studies To Labeling

 
• By Sue Sutter

Some advisory committee members said adding quantitative data on misuse, abuse, opioid use disorder and overdose to labeling would be helpful, but others worried the two epidemiological studies were not sufficiently generalizable to a broader population.

Updated: Makary Backs New Novavax COVID-19 Trial, Political Officials Take Over Product Review

 
• By Sarah Karlin-Smith

In an unusual move, Tracy Beth Høeg, a special assistant to FDA Commissioner Martin Makary, is leading the continued negotiations on Novavax’s delayed COVID-19 vaccine approval.

More from Product Reviews

US FDA’s July AdComms: Pediatric Vaccine Safety, Blenrep’s Return, (Maybe) Capricor’s Cell Therapy

 
• By Sue Sutter

The Pediatric Advisory Committee will review postmarketing safety for three vaccines and the oncologic drugs panel will consider the return of GSK’s belantamab mafodotin. An FDA notice about a 30 July meeting on Capricor’s deramiocel for Duchenne muscular dystrophy was withdrawn.

Recent And Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

Blenrep’s Comeback Continues As England Becomes First To Fund Drug

 
• By Eliza Slawther

Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.