Generic Drug Approvals
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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.