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Collegium Pharmaceutical Inc.

www.collegiumpharma.com

Latest From Collegium Pharmaceutical Inc.

New Opioids: Industry Stakeholders Support US FDA's Desire For Active Comparator Data

Although only a few companies commented on the FDA's draft guidance on the benefit/risk assessment of new opioids, they cut against conventional wisdom by supporting the agency's desire to see active comparator data.

Guidance Documents Neurology

FDA Warns Lymol To Assess Talc Lead Risk Per ICH Q3D; Puts Others On Notice

A warning letter to firm with legacy talc drug product puts pharmaceutical industry on notice: the US FDA expects applicants to meet requirements agency imposes post-approval for matters like elemental impurities compliance.

Enforcement Quality

Ascend’s EstroGel Promotion Misrepresents Efficacy Compared To Other Products, US FDA Says

Professional sell sheet falsely suggests estradiol gel contains lowest effective dose of estrogen compared to other estrogen products, OPDP says in fourth “untitled” letter of 2018.


Advertising, Marketing & Sales Compliance

US FDA Reprimands Arog Pharmaceuticals For Promo Of Investigational AML Drug

Third enforcement letter of the year cites meeting exhibit and webpage that suggest crenolanib is safe and effective for an unapproved use.

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Company Information

  • Industry
  • Biotechnology
  • Pharmaceuticals
    • Drug Delivery
      • Controlled Release
  • Therapeutic Areas
  • Neurology, Nervous System
  • Alias(es)
  • Ownership
  • Public
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Parent & Subsidiaries
  • Collegium Pharmaceutical Inc.
  • Senior Management
  • Michael Heffernan, Pres. & CEO
    Paul Brannelly, EVP, CFO
    John Weet, PhD, VP, Reg. Affairs & Quality Assurance
    Joseph Ciaffoni, EVP, COO
    Raimonds Dzelme, VP, Mktg.
    Jack Maroney, VP, Sales
    Alison B Fleming, PhD, CTO
    Richard Malamut, MD, CMO
  • Contact Info
  • Collegium Pharmaceutical Inc.
    Phone: (781) 713-3699
    780 Dedham St.
    Ste. 800
    Canton, MA 02021
    USA
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