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Latest From Janssen R&D LLC

Risk-Based Monitoring: US FDA Clarity And Industry Standards Aren't Enough

Only a culture shift can move sponsors away from traditional monitoring to risk-based approaches, a transition being slowed by fear of change as well as confusion resulting from too many ‘flavors’ of risk-based monitoring strategies, stakeholders say; FDA tries to clarify what risk-based monitoring is, and is not.

Clinical Trials Compliance

Benefit-Risk Math: US FDA Still Favors Simple Calculations

A core group of big pharma companies has been pressing FDA for over a decade to adopt a quantitative formula for conducting and communicating benefit-risk decisions. FDA has changed its benefit-risk calculations in response – but not its basic way of doing the math.
Drug Approval Standards Drug Review

Real-World Evidence: Observational Studies Deserve More Respect In US FDA Framework

Biopharma industry urges agency to open the door wider to use of non-randomized observational studies to support efficacy claims, but insurer Kaiser Permanente calls such studies problematic.

Drug Approval Standards Clinical Trials

REMS Statutory Factors Weighed On Case-By-Case Basis, US FDA Says

US FDA rebuffs PhRMA’s request to clarify how the six statutory factors are weighed and to explain how it decides what a REMS should look like. All six factors are considered together to inform agency’s decision-making on the need for a Risk Evaluation and Mitigation Strategy, according to final version of guidance first issued in 2016.


Risk Management Drug Safety
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