(Food and Drug Law Institute: Washington) -- To help organizations stay in compliance with Food and Drug Administration (FDA) regulations, the Food and Drug Law Institute is hosting the “Introduction to Drug Law and Regulation: A Program on Understanding How the Government Regulates the Drug Industry,” June 25-26, 2009 at L’Enfant Plaza Hotel in Washington, D.C.

The two-day program, aims to teach the essential elements of the laws and regulations that affect companies in the drug industry. From the definition of “drug” to the different regulatory schemes for over-the-counter (OTC) and prescription (Rx) drugs, the lectures cover the major statutory provisions and regulations. The program includes a broad overview of the FDA, the history of drug regulation, and details on specific areas of drug regulation.

Participant’s will examine FDA’s role in managing the drug approval process and how that process governs competition between branded and generic drugs. Additionally, attendees will become more familiar with many of the acronyms used in the drug arena, such as ANDA (abbreviated new drug application), IND (investigational new drug), NDA (new drug application), PDUFA (Prescription Drug User Fee Act of 1992–USA), and gain a clearer understanding of how FDA enforces and implements the laws handed down by Congress.

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