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Decreasing regulatory burden on manufacturers – approval of new dosage strengths of existing products

  • In: A7 - Regulatory facilitation of access to medicines on Wednesday, 3 September 2014, 9:00-12:00
  • At: Bangkok (Thailand) (2014)
  • Type: Presentation
  • By: SHAH, Vinod (FIP, North potomac, md, United States of America)
  • Abstract:

    A new chemical entity is approved as a drug product after safety and efficacy are confirmed. As a result of Drug Price Competition and Patent Term Restoration Act (Waxman-Hatch Bill, 1984), a generic product can get approval by documenting both pharmaceutical equivalence and bioequivalence with the reference product. Many of the orally


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Last update 28 September 2023

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