Posted on December 4, 2009 by Debra A. McCurdy

FDA Guidance Documents

This post was written by Paul Sheives.

FDA released a number of final and draft guidance documents in November, including the following:

  • Draft Guidance for Industry on Assay Development for Immunogenicity Testing of Therapeutic Proteins;
  • Draft Guidance for Industry: Factors That Distinguish Liquid Dietary Supplements From Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods;
  • Draft Guidance for Industry on Dosage Delivery Devices for Over-the-Counter Liquid Drug Products;
  • International Conference on Harmonisation; Draft Guidance on E7 Studies in Support of Special Populations; Geriatrics; Questions and Answers;
  • Guidance for Industry on Residual Solvents in Drug Products Marketed in the United States; and
  • Several final and draft guidance documents on tobacco products, including guidance on listing of tobacco ingredients, applications for modified risk tobacco products, and registration of owners and operators of tobacco product establishments.
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