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Former FDA Commissioner Frank Young Passes Away At 88

From the approval of AZT to the generic drug scandal, Frank Young oversaw many seminal events at US FDA while commissioner from 1984 to 1989. After leaving the agency, he managed the approval of the NDA for Braeburn's opioid dependence drug Probuphine. Young passed away following a short bout with cancer.

FDA Leadership

US FDA Revokes Orphan Drug Designation For Indivior’s Sublocade

In first-of-its-kind decision, agency concludes it relied on unreasonable assumptions regarding total market size, and failed to consider information about other dosage formulations, in granting designation for buprenorphine under the cost recovery provision; however, the FDA reaffirms that scope of Sublocade’s three-year exclusivity will keep Braeburn’s Brixadi off the market for another year.

Legal Issues FDA

US FDA Must Explain How It Defines ‘Innovation’ In Awarding Hatch/Waxman Exclusivity, Court Says

Agency's decision that Indivior’s Sublocade blocked Braeburn’s long-acting buprenorphine formulation Brixadi lacked ‘substantive guideposts’ in how innovation is defined for purposes of deciding scope of three-year exclusivity, US judge says.

Legal Issues FDA

US FDA, Advisory Committees Rarely Disagree

A Milbank Quarterly study and a Pink Sheet analysis show that disagreement between the US FDA and its advisory committee meetings doesn't happen often; it is even rarer for the agency to approve a drug against the advice from a panel.

Advisory Committees Approvals
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Company Information

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  • Biotechnology
  • Medical Devices
  • Pharmaceuticals
  • Pharmaceuticals
    • Drug Delivery
      • Controlled Release
  • Medical Devices
    • Consumables, Central Supplies
    • Implantable Devices
    • Infection Control-Sterilization
    • Infusion Therapy Equipment and Supplies
    • Laser
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    • Surgical Equipment & Devices
      • Minimally or Less Invasive
  • Other Names / Subsidiaries
    • Braeburn Pharmaceuticals
    • Elstar Therapeutics
    • Tokai Pharmaceuticals, Inc.
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