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Barry A. Friedman, PhD LLC

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

TOP POSTINGS FROM THE BLOG OF BARRY A FRIEDMAN, PHD

April 13, 2012 By Barry Friedman Leave a Comment

A RESPONSE TO YOUR QUERIES RE: FREQUENT TOPICS OF INTEREST

Periodically, I am asked what are the most frequent topics which interest the reader. Because the reader has so many varied interests, it is difficult to determine this without retrospectively reviewing the data.  I have summarized below the “top six” topics that have been viewed since the beginning of 2012.  You may wish to look at what others are viewing.   On a Quarterly basis, I will begin to list these for your review/comments.  Thanks for viewing my Postings this year.

1)   FDA Increases Vigilance on Aseptic Processing Facilities

2)   Ben Venue Receives Yet Another Form FDA 483

3)   USP 61/62 Frequently Asked Questions

4)   FDA Issues Warning Letter for Clinical Supply Manufacturing Facilities

5)   Proposed Changes to USP General Chapter 823 March 30, 2011

6)   2012 Upcoming Webinar/Seminars

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Filed Under: 483, FDA Compliance, Regulatory Compliance, Warning Letters, Webinar Tagged With: Ben Venue, FDA 483, USP 823, Warning Letters, webinars/seminars

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Webinar Registration & Information

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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