Publications

Dr. Robert Schiff has published a number of articles on the subject of regulatory affairs and compliance in the pharmaceutical industry. Some may be accessed by the following links.

2007. Dietary Supplements: Past Compliance and the Future. Regulatory Affairs Focus. 12(12):14-16

2008. Some Thoughts on Current Good Manufacturing Practices. Regulatory Focus. 13(7):44-47

2009. Botanical Products: Drugs and Dietary Supplements. Regulatory Focus 14(8):12-16

2009. Medical Device Submissions. In Fundamentals of US Regulatory Affairs, 6th Ed., Berry, P.J. and Takes, eds. Regulatory Affairs Professional Society. Rockville, MD. pp.201-215

2010. Compliance and the Start-up Company. Regulatory Focus. 15(5):8-10

2010. Good Clinical Practice Compliance and the Start-up Company. Regulatory Focus. 15(5):26-32