Events
Duane Morris Special Counsel Michael Swit to Present "Generic Drug Approvals"
August 13, 2013 | New Brunswick, NJ
Duane Morris special counsel Michael Swit will co-direct a three-day course on "Generic Drug Approvals," to be held Tuesday, August 13, 2013 through Thursday, August 15, 2013 in New Brunswick, New Jersey. The course is offered by the Center for Professional Advancement (CfPA)
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
When Congress passed the Drug Price Competition and Patent Term Restoration Act of 1984 (the Hatch-Waxman 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, as well as incentives for generic firms to challenge branded patents.
This course will review the basic provisions of the Hatch-Waxman 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.
To learn more and to register, please visit the CfPA website. Use discount code CD1462 to save 10% on registration.
