1st Nanoparticulate drugs approved by FDA

On Mondaq (free reg required), Foley & Lardner has published a writeup on the first FDA approval of nanoparticulate drugs: “As nanotechnology companies emerge in the pharmaceutical market, they will have to develop the capability to navigate through the regulatory waters. Until recently, federal agencies had not faced the question of whether to approve a drug based on nanotechnology. Several companies, however, presented new issues to federal regulators when they developed nanoparticulate drugs and sought approval. In this article, Mary C. Till, Michele M. Simkin and Stephen Maebius examine recent success stories of companies who sought and won approval of these nanoparticulate drugs and outline the approval process for future nanotechnology based drugs.”

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