New challenges face the pharmaceutical and medical device industries each day. It is imperative that in-house counsel as well as defense firms stay current on new risks — and opportunities — to best advise the corporations they represent.

Andy Tauber will speak on “The Intersection of FDA Medical-Device Enforcement and Product-Liability Litigation” 

  • Voluntary compliance: how to avoid actions
  • Costs of non-compliance
  • GMP-based warning letters and consent decrees
  • Corporate-wide compliance
  • Defending against private plaintiffs’ use of alleged FDCA violations

Hank Bullock will speak on “Getting the Word Out:  Labeling & Promotion for Brands/Generics”

  • Coronia/Solis and other First Amendment cases regarding off-label marketing
  • Regulatory update for generic manufacturers
  • Post-Mensing case developments
  • Report on failure-to-update claims
  • Status of proposed FDA regulations

Event webpage:

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