- Recon: J&J nabs FDA authorization for general surgery robot; FDA urged to ban DTC drug ads<p>Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.</p>raps · 1d ago↗ source
- Euro Roundup: EMA seeks feedback on planned changes to guidance on biosimilar efficacy studies<p>The European Medicines Agency (EMA) has released a draft concept paper on planned changes to its guideline on similar biological medicinal products.</p>raps · 1d ago↗ source
- Study: Most sponsors complete postmarketing trials, publish results<p>Postmarketing requirements and commitments were completed for nearly nine out of ten drugs approved by the US Food and Drug Administration, with such requirements or commitments assigned at the…