Generic Drug Approvals Training Course :

<strong>Course Schedule - May 4-6, 2009</strong><br/><br/>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.<br><br> 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.