Agency plans guidance on whether observational studies can provide real-world evidence to support regulatory decisions about drug effectiveness; however, RWE framework includes critical questions about retrospective studies, and reflects agency concerns about transparency.
The US FDA’s real-world evidence (RWE) framework takes a cautious approach to the use of observational studies to support new efficacy claims for approved drugs.
The agency intends to issue guidance about observational study designs using real-world data (RWD), including how such studies might provide...
While drug regulators are “conservative” by nature, the European Medicines Agency wants to help companies rather than rip their dossiers “into little pieces,” a senior regulatory assessor says.
Drawing on around 60 years of experience, the European Directorate for the Quality of Medicines & HealthCare will help the newly formed African Medicines Agency develop robust quality control systems.
CDER Director George Tidmarsh said in a now deleted social media post that his center will evaluate surrogate endpoints. Tidmarsh mentioned "notable failures," including a lupus drug, where he has past business connections to the sponsor's board chair.
Sponsors may need to pursue more rapid CMC development to accommodate the faster pace of the clinical program, the FDA said in a new expedited pathways guidance, which also addresses product changes after RMAT designation and the use of real-world evidence to confirm clinical benefit.
Drawing on around 60 years of experience, the European Directorate for the Quality of Medicines & HealthCare will help the newly formed African Medicines Agency develop robust quality control systems.
CDER Director George Tidmarsh said in a now deleted social media post that his center will evaluate surrogate endpoints. Tidmarsh mentioned "notable failures," including a lupus drug, where he has past business connections to the sponsor's board chair.
FDA shutdown plans indicate about 86% of staff would be retained, a rate that is higher than previous plans, but reserve funding would not last more than a few months.
