Generic Drug Approvals
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Who Should Attend
This overview course is intended for personnel from generic
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 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.
Other Courses of Interest
Active Pharmaceutical Ingredients
Apr 27 2009, New Brunswick, NJ
CMC Submissions in CTD Format
Feb 09 2009, Boca Raton, FL
Excipient GMPs
Scale-Up and Post Approval Changes Guidelines (SUPAC & API Changes)
Apr 06 2009, Amsterdam, The Netherlands
Scale-Up and Post Approval Changes Guidelines (SUPAC & API Changes)
Jun 08 2009, New Brunswick, NJ
INDs/NDAs/CTDs
Mar 09 2009, Burlingame, CA
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