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Novartis Pharmaceuticals Corp.

Division of Novartis AG
www.pharma.us.novartis.com

Latest From Novartis Pharmaceuticals Corp.

FDA Gets Final With Guidance On Recall Public Warnings, Notifications

There may be fewer recalls, but they are getting more publicity, in part because of FDA warnings that one recalcitrant firm said “decimated” sales.

Recalls Manufacturing

Recall-Related Public Warnings Get Final US FDA Guidance

There may be fewer recalls, but they are getting more publicity, in part because of FDA warnings that one recalcitrant firm said “decimated” sales.

Product Recalls Quality

Adaptive Clinical Trial Designs: US FDA Provides Checklist To Begin Study

Draft guidance specifies documentation that must be submitted to FDA prior to conducting an adaptive trial, and what to include in an application.

BioPharmaceutical Regulation

The Quality Lowdown: Novartis/Sandoz Child-Resistant Packaging; Solvent Testing; Quality Metrics; Cell And Gene Therapy

Why did Novartis/Sandoz’s hospital blister packs have to be child-resistant? Why did two warning letters to Chinese firms follow promises of more, better testing? And should firms should consider volunteering for new FDA quality metrics programs (or not) and a pre-competitive industry collaboration on cell and gene therapies?

Manufacturing Quality
See All

Company Information

  • Industry
  • Pharmaceuticals
  • Therapeutic Areas
  • Cancer
  • Cardiovascular
  • Immune Disorders
  • Neurology, Nervous System
  • Ophthalmic
  • Respiratory, Pulmonary
  • Alias(es)
  • Ownership
  • Private
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Parent & Subsidiaries
  • Novartis AG
  • Senior Management
  • Meryl Zausner, VP, CFO & Chief Administrative Officer
    Christi Shaw, Pres.
    Cathryn M Clary, MD, Head of US Medical, CMO
    Keith Riddiford, VP & Head, Commercial Support Organization
  • Contact Info
  • Novartis Pharmaceuticals Corp.
    Phone: (973) 781-8300
    1 Health Plaza
    East Hanover, NJ 07936-1080
    USA
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