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FDA follow-on biologics workshop

Executive Summary

FDA schedules public workshop on "follow-on protein products" for Sept. 14 and 15. "Because of the scientific complexity of protein pharmaceutical products, FDA intends to conduct an extensive public dialogue on the scientific issues relating to the development and approval of such products," the 1FDA notice of the workshop states. The workshop will not address legal or regulatory issues. An FDA/DIA meeting on follow-on biologics is expected to take place in 2005 (2"The Pink Sheet" Aug. 9, 2004, p. 10). The workshop will be held at the University of Maryland Shady Grove Conference Center in Rockville, Md. starting at 8:30 a.m. on Sept. 14 and at 8 a.m. on Sept. 15...

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