CDER guidance for generics offers some help to OTC drug makers, but FDA may incorporate guidance in monographs.(Impurities): An article from: Validation Times
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This digital document is an article from Validation Times, published by Washington Information Source, Inc. on October 1, 2009. The length of the article is 950 words. The page length shown above is based on a typical 300-word page. The article is delivered in HTML format and is available immediately after purchase. You can view it with any web browser.
Citation Details Title: CDER guidance for generics offers some help to OTC drug makers, but FDA may incorporate guidance in monographs.(Impurities) Author: Melissa Winn Publication:Validation Times (Newsletter) Date: October 1, 2009 Publisher: Washington Information Source, Inc. Volume: 11 Issue: 10 Page: 1(3)