Discover how outsourcing regulatory submission content development improves efficiency and ensures compliance.
Cameron Hoyler is the general counsel, corporate secretary, and executive vice president of PolarityTE, Inc., a Nasdaq-listed ...
Key regulatory trends laying the foundation for updated policies, risk-based regulatory frameworks, and forward-looking ...
Stereotaxis (STXS) announced FDA regulatory submission for the MAGiC Sweep catheter. MAGiC Sweep is the first high-density EP mapping catheter ...
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Stereotaxis Stock Slides Despite MAGiC Sweep Catheter FDA SubmissionStereotaxis STXS recently submitted an application seeking FDA regulatory clearance for its MAGiC Sweep catheter, which is ...
Exploring Regulatory Affairs, the discipline dedicated to ensuring that new drugs and biologics are safe, effective, and ...
The study found that just 20% of trials submitted to both the FDA and European Medicines Agency had matching evidence.
The Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for depemokimab for asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps ...
The partners are building toward a regulatory submission for Tezspire in chronic rhinosinusitis with nasal polyps in the ...
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