Discover how outsourcing regulatory submission content development improves efficiency and ensures compliance.

Exploring Regulatory Affairs, the discipline dedicated to ensuring that new drugs and biologics are safe, effective, and ...

Key regulatory trends laying the foundation for updated policies, risk-based regulatory frameworks, and forward-looking ...

Stereotaxis STXS recently submitted an application seeking FDA regulatory clearance for its MAGiC Sweep catheter, which is ...

Stereotaxis (STXS) announced FDA regulatory submission for the MAGiC Sweep catheter. MAGiC Sweep is the first high-density EP mapping catheter developed to be robotically navigated using ...

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 ...

Active surveillance using routine health data can improve patient safety The US Food and Drug Administration (FDA) requires manufacturers of medical devices, such as ventilators and defibrillators, to ...

Amneal Pharmaceuticals (AMRX) “announced that the FDA has accepted for review its Biologics Licensing Application for two proposed denosumab ...