Course offering number:0805-301
Course ID:
1462
Generic Drug Approvals
May 14-16, 2008
New Brunswick, NJ
Who Should Attend
This overview course is intended for personnel from generic and
brand name drug manufacturers and bulk drug substance
suppliers who seek a broad and thorough understanding of the
legal, regulatory, and practical aspects of developing and
compiling Abbreviated New Drug Applications (ANDAs) and
obtaining FDA approval of generic drugs, including:-
Regulatory Affairs
- Technical/Scientific/Research
- QA/QC
- Management
- Legal/Compliance
- Manufacturing
Description
When Congress passed the Drug Price Competition and Patent
Term Restoration Act of 1984 (the “Waxman-Hatch Act”), it
enabled the pharmaceutical industry to seek approval via an
ANDA of generic versions of the vast majority of drugs
approved by FDA since 1962. New, complex requirements
were imposed on persons seeking FDA approval of these
generic drugs. Congress also created incentives to encourage
development of new branded products, including extended
patent protection and periods of non-patent market exclusivity.
This course will review the basic provisions of the Waxman-
Hatch Act; the information and data required for an ANDA;
which drugs are eligible for submission under an ANDA and
why; the role of patent protection and market exclusivity; pitfalls
and pointers in dealing with the FDA review process;
bioequivalence testing; and changing pending ANDAs and Drug
Master Files (DMFs). Particular attention will be given in the
course to the impact of FDA's regulations and guidances on
both paper and electronic ANDAs.