Menu
  • Join
  • Login
  • Contact
 

Search abstracts


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

  • At: 2014 FIP Congress in Bangkok (Thailand)
  • 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

    ..

  • The access to the whole abstract and the presentation file is available to FIP members and to congress participants of that specific congress. Please login
Last update 4 October 2019

FIP Congresses