Insights

In the wake of the worldwide 2009 H1N1 pandemic, federal agencies are closely scrutinizing statements in advertisements and on labels that claim products are effective against the H1N1 flu virus. Makers of a host of products - from drugs and medical devices to dietary supplements and household consumer products - are trying to capitalize on the health concerns associated with this virulent new strain of influenza. Federal agencies are not only battling H1N1, they are also dedicating substantial resources to rooting out deceptive or unauthorized claims; and are taking aggressive enforcement action against companies that are marketing products with unapproved, uncleared, unauthorized or unsubstantiated H1N1 claims. Federal agencies most active include the U.S. Food and Drug Administration ("FDA"), the Federal Trade Commission ("FTC") and the U.S. Environmental Protection Agency ("EPA").

This is the premier course to help you and your organization understand FDA regulations for drug products. By attending this two day program, you will learn the essential elements of the laws and regulations that affect you in the drug industry. From the definition of “drug” to the different regulatory schemes for over-the-counter (OTC) and prescription (Rx) drugs, this meeting walks you through the major statutory provisions and regulations, and helps you develop a clearer understanding of how they work. You will receive a broad overview of FDA, the history of drug regulation, and details on specific areas of drug regulation. Additionally, you will examine FDA’s role in managing the drug approval process and how that process governs competition between branded and generic drugs. This program will help you think like an experienced drug professional. You will become more familiar with many of the acronyms used in the drug arena, such as, ANDA, IND, NDA, PDUFA and others. Further, you will gain a clearer understanding of how FDA enforces and implements the laws handed down by Congress. You will learn how all of these provisions and regulations affect what you do every day. This program will also cover the latest topics and important new developments affecting the drug industry, including prescription drug imports, risk management, OTC switches, Hatch-Waxman reform, and more.