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AcelRx Pharmaceuticals Inc.

www.acelrx.com

Latest From AcelRx Pharmaceuticals Inc.

US FDA's Decade In Review: From Biosimilars To Real-World Evidence

A look back over FDA actions during the past 10 years shows the evolution of its policies on opioids, preemption, off-label promotion and use of real-world evidence.

FDA Biosimilars

Nektar's Novel Opioid For Lower Back Pain Heads To US FDA Panel For Wide-Ranging Discussion

Nektar's novel opioid oxycodegol will be the first opioid analgesic taken up by an advisory committee in more than a year after the agency spent 2019 reevaluating its regulatory paradigm.

Advisory Committees Neurology

Comparative Confusion: What Does FDA Intend For Opioid Comparative Efficacy Data?

Legally, FDA can't require comparative effectiveness data for approval, but draft guidance notes that the agency really wants it; for sponsors, that leaves more questions than answers, mainly: What will FDA do with an opioid application that doesn't contain such data.
Comparative Effectiveness Drug Approval Standards

Dsuvia: A Dull US FDA Review Preceded The Controversial Approval

US FDA's review of AcelRx's opioid Dsuvia did not presage the external fireworks that came following the approval.

Drug Review Profile Neurology
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Company Information

  • Industry
  • Biotechnology
  • Medical Devices
  • Pharmaceuticals
    • Drug Delivery
  • Therapeutic Areas
  • Neurology, Nervous System
  • Alias(es)
  • SuRx Pharmaceuticals Inc.
  • Ownership
  • Public
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Parent & Subsidiaries
  • AcelRx Pharmaceuticals Inc.
  • Senior Management
  • Vincent J Angotti, CEO
    Raffi Asadorian, CFO
    Larry G Hamel, Chief Dev. Officer
    Pamela P Palmer, MD, PhD, CMO
    Mark A Evashenk, VP, Clinical Operations
    Kim Gaumer, VP, Reg. Affairs & Quality Assurance
  • Contact Info
  • AcelRx Pharmaceuticals Inc.
    Phone: (650) 216-3500
    351 Galveston Dr.
    Redwood City, CA 94063
    USA
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