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.
Other Courses of Interest
Active Pharmaceutical Ingredients
May 21 2012, New Brunswick, NJ
Active Pharmaceutical Ingredients
Jun 27 2012, Amsterdam, The Netherlands
Best Practices in SAS Statistical Programming for Regulatory Submission
CMC Submissions in CTD Format
May 17 2012, New Brunswick, NJ
Developing Specifications for Drug Substances and Drug Products
May 07 2012, Burlingame, CA
Excipient GMPs
ICH-Q7
Mar 19 2012, New Brunswick, NJ
ICH-Q7
Jun 25 2012, Amsterdam, The Netherlands
Scale-Up and Post Approval Changes Guidelines (SUPAC & API Changes)
Feb 27 2012, New Brunswick, NJ
Scale-Up and Post Approval Changes Guidelines (SUPAC & API Changes)
Jun 11 2012, Amsterdam, The Netherlands
INDs/NDAs/CTDs
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