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News From the Food and Drug Administration
May 1, 2002

FDA-PPTA Workshop

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JAMA. 2002;287(17):2203. doi:10.1001/jama.287.17.2203-JFD20005-2-1

The FDA and the Plasma Protein Therapeutics Association (PPTA) will conduct on May 30-31 a public workshop entitled "Comparability Studies for Human Plasma-Derived Therapeutics." The workshop, to be held at the Doubletree Executive Meeting Center, 1750 Rockville Pike, Rockville, Md, will discuss among other issues the FDA perspective on the design of clinical studies to evaluate comparability of plasma-derived therapeutics. The goal is to provide sponsors with information that will increase their ability to bring such products to market. For registration and additional information, log on to http://www.fda.gov/cber/whatsnew.htm.