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Barry A. Friedman, PhD LLC

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

FDA’s CDER LISTING OF TOP NINETEEN OBSERVATIONS FOR 2015 – NOW AVAILABLE

April 27, 2016 By Barry Friedman 1 Comment

TOP FOUR OBSERVATIONS RETAIN SIMILAR ORDER TO 2013 AND 2014 Each fiscal year the FDA issues the various FDA 483 Observations from the various Centers to include CBER, CDER, CDRH, etc.  This Blog focuses only upon those issued by the Center for Drug Evaluation and Research (CDER) and will concentrate upon those FDA' CDER listing found within 21 CFR Part … [Read more...]

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FREQUENTLY ASKED QUESTIONS:

FDA Form 483 Frequently Asked Questions

USP General Chapter

USP General Chapter 62, Part II

TOP OBSERVATIONS:

FDA’s CDER LISTING OF TOP NINETEEN OBSERVATIONS FOR 2014

FDA CDER Most Frequent Form FDA 483 Observations Fiscal Year 2012

CDER MOST FREQUENTLY CITED DRUG OBSERVATIONS – FISCAL YEAR 2010

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Top Posts for 2012

Top Posts for 2013

Top Posts Year To Date

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