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Barry A. Friedman, PhD LLC

FDA Regulatory Compliance for the Pharmaceutical, Biotechnology and Medical Device Arenas

Frequently Asked Questions (FAQ) About Combination Products

January 13, 2016 By Barry Friedman Leave a Comment

Recently the Office of Combination Products published a list of ”Frequently Asked Questions (FAQ)” that are often asked of the Office.  This list of approximately twenty eight questions include several questions with rather obvious answers as well as questions that include where to obtain additional information regarding annual reports. The list includes the roles of the … [Read more...]

FREQUENTLY ASKED QUESTIONS — USP GENERAL CHAPTER 62, PART I (REVISED)

June 19, 2012 By Barry Friedman 6 Comments

COMMENT The USP has recently released a Summary of Frequently Asked Questions (FAQ) for both USP <61> and <62>.  The FAQ for USP <61> was previously posted in another Blog.  The FAQ listed below is the first of two Parts discussing additional FAQ from USP <62>.  Additional FAQ will be posted later in the week. Microbial Examination of Nonsterile … [Read more...]

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