Efficacious and Safe Drug Labeling Strategies - The Access to Affordable Medicines Act


This article discusses U.S. drug labeling strategies used by brand (also referred to as innovator) and generic pharmaceutical companies, including the most recent proposed drug labeling changes in the Access to Affordable Medicines Act (AAMA). In particular, the overlap of patent protection, labeling, and Food and Drug Administration (FDA) approval are discussed in the context of the regulatory framework and history of drug labeling, and the currently pending health care legislation.

Excerpted from Health Law Reports, Vol. 3, No. 2, February 2010 © Bloomberg Finance L.P. Originally published by Bloomberg Finance LP. Reprinted by permission. The full article appears in the PDF below.

For more information contact Jeff Wolfson.

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