Guide

Welcome to GxP Perspectives. (formerly, Carl’s Blog on FDA Stuff)

The Blog is organized in a rather simple manner. There are:

POSTS, with comments on a current development with, or relating to, the U.S. Food & Drug Administration, best practices for GxP professionals, and other informational offerings presented in chronological order. Some posts are mine and some are by GxP professionals who have written Guest Commentaries.

At the top there are:

Discussing the Issues for Drug and Device Development

PAGES, with articles I have written, book reviews by Sid Olufs, a professor at Pacific Lutheran University, About Carl, a short biography of Carl & the Blog, and this guide. I have recently added a page regarding the Trial Master File, the TMF for clinical trials. I have a number of links to FDA, EMA, and other interesting documents that I hope you find of use. Please let me know of others! Another new feature is Guest Commentaries. I have asked GxP professionals, people with a lot in common with you, to talk about protocol deviations; CAPA- corrective and preventative action; the TMF; the regulation of clinical trials and chemicals in Europe; GCP training, and other great stuff. Perhaps you would like to submit a Guest Commentary?

Along the right hand side the column has:

Email Subscriptions: Please subscribe!

A Search feature

TOPICS: A dropdown list that lists posts by the topic. There are 11 topics including EIRs (inspection reports); FDA (issues directly from FDA); FDA Commentaries: Food Safety; GCP (Good Clinical Practice); General (what doesn’t fit into a specific topic); GLP ( Good Laboratory Practice); Guidance Documents; GxP (regulatory compliance not pertaining to a clinical or nonclinical study); Research Ethics (including IRBs and Informed Consent); and Warning Letters issued by FDA.

RECENT POSTS

TOP POSTS: What people are reading.

BLOGROLL, which includes more than blogs. There are a number of online newsletters and organizations that may be of interest to you. They were selected to give the reader a broad spectrum of the news, resources, and opinions about FDA. At the top of the Blogroll is a link to the homepage of FDA.

IMPORTANT REFERENCES

And for both the POSTS and PAGES there is a place for your input:

COMMENTS, I welcome any and all comments, advice, suggestions, and your opinions, regardless of your political/social point of view. I will answer any comment or question if presented in a collegial manner. I will not accept or post lewd or angry comments that remind me of a cable talk show or the walls of a high school men’s room.

I would like this Blog to be a useful resource for you as well as a place you can find out about interesting developments in the world of FDA and other regulatory agencies, as well as my analysis of FDA and GxP stuff. I don’t want to yell at anyone, so you won’t find any polemics (not too much, anyway). I have also made several attempts at humor and commentary on the human condition.

THANKS AGAIN!

Carl-
====
You can help out GxP Perspectives! Please let your colleagues and friends know about GxP Perspectives. I also encourage you to get an email subscription (on the sidebar to your right), follow GxP Perspectives on twitter or join the LinkedIn group (below).

GxP Perspectives LinkedIn Group

GxP Perspectives on twitter: @GxPPerspectives

.
====

Other References:

The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006

Ball-Harmonizing Regulatory Approaches to Clinical Trials

FY09 BIMO data