Evidence
Vinay Prasad Details New Approach to COVID-19 Vaccine Approvals in Recent FDA Memos
Vinay Prasad; COVID-19 vaccine; FDA; vaccine approval; children; Spikevax; regulatory decisions; vaccine safety; evidence; risk-benefit analysis
Federal Appeals Court Overturns FDA Rejection of Vanda’s Hetlioz for Jet Lag Disorder
Vanda Pharmaceuticals; Hetlioz; FDA; jet lag disorder; Federal Appeals Court; supplemental New Drug Application (sNDA); regulatory law; clinical trial evidence
Pragmatic Clinical Trials: Bridging the Gap Between Research and Real-World Practice
1. Pragmatic Clinical Trials, 2. Real-World Evidence, 3. Clinical Trial Design, 4. Effectiveness Research, 5. Healthcare Decision Making
HLTH24: Atropos Health Introduces AI-Powered Chat Co-Pilot for Rapid Real-World Evidence Generation
Atropos Health, HLTH24, Chat-Based AI Co-Pilot, Real-World Evidence, Generative AI, Healthcare Evidence Generation, GENEVA OS, ChatRWD
Highlander Health: Revolutionizing Clinical Research with Integrated Solutions
Highlander Health, clinical research, personalized healthcare, evidence generation, technology enablement, Amy Abernethy, Brad Hirsch, Verily, FDA.
Lykos Faces Setback as ICER Concludes Insufficient Evidence for MDMA-Based PTSD Treatment
Lykos Therapeutics, MDMA, PTSD, ICER, Insufficient Evidence, Clinical Trials, FDA Approval