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)
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.