Mark your calendars for Questioning the Bioequivalence Standards for Antiepileptic Drugs: Implications for Regulation of Narrow Therapeutic Index Drugs, a conference sponsored by the University of Maryland Center of Excellence in Regulatory Science and Innovation and the Food and Drug Administration.
About the Event:
Approximately 85 percent of prescriptions dispensed are generic drugs. These drugs have saved billions of dollars since 1984, with few documented cases of inequivalence. However, the FDA’s approach for determining the bioequivalence between generic and brand products has met with some controversy since the establishment of the Abbreviated New Drug Application (ANDA) process by the Hatch-Waxman Amendments.
This conference, scheduled for Monday, May 12, 2014 at the FDA’s White Oak Campus will discuss the effectiveness of current regulatory standards governing generic drug approval, including the most appropriate and acceptable approach for assessing generic bioequivalence to ensure therapeutic equivalence. Because it has been argued that current bioequivalence standards may not be sufficient in special patient populations (e.g., generic brittle epilepsy patients) using antiepileptic drugs (AEDs), the focus will be AED bioequivalence in epilepsy patients. The ongoing project for AED approval for pediatrics for NDA will also be discussed. Conclusions drawn from this conference may be relevant for the regulatory oversight of other therapeutic categories as well, such as immunosuppressant drugs.
About the Sponsor:
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The Center of Excellence in Regulatory Science and Innovation (CERSI) focuses on modernizing and improving the ways in which drugs and medical devices are developed and evaluated. It is a collaborative partnership between the Food and Drug Administration (FDA) and the Baltimore and College Park campuses of the University of Maryland. |
For More Information:
More information, including registration, agenda, and information about the White Oak campus, can be found on this website.