Title:
Immel Resources LLC - Comment

Abstract:
Barbara Immel, Immel Resources LLC - ...FDA News Audioconference, January 30, 2008 Barbara K. Immel, President, Immel Resources LLC and Editor, Immel Report™ Petaluma, CA....

Title:
Immel Resources LLC - Comment

Abstract:
Barbara Immel, Immel Resources LLC - ...I am opposed to the direct final rule to amend the pharmaceutical good manufacturing practices (21 CFR 210/211). I believe that if it is enacted as currently written, it may open American drugs and biologics to a level of contamination or cross contamination that we have not yet seen or imagined, putting all Americans at risk....

Title:
Immel Resources LLC - Comment

Abstract:
Barbara Immel, Immel Resources LLC - ...I submitted all of the materials such that they could be posted on-line. We also faxed them in for that reason. The slides and newsletter are in the public domain....

Title:
Immel Resources LLC -Comment

Abstract:
Barbara Immel, Immel Resources LLC - ...Immel Report Vol 2 Spring 2006 - Advice and guidance for managers in fda-regulated industries. "Chipping Away at the GMPs: FDA’s Phase 1 Proposals" by Barbara Immel....