Drug Regulatory Affairs and Compliance for Human Drug Products

Introduction: This site attempts to provide current sources of drug law, regulations, guidelines and other information issued by the US FDA via the internet relevant to the registration of applications and CGMP compliance for human drug products. assembled by Bruce G. Berger

Table of Contents

The best single source for concise general information about the regulatory environment of the FDA can be found at its Small Business site. More detailed information can be found at the references below. The information provided below is part of what can be considered the "regulatory hierarchy pyramid" which defines the regulatory environment.

Information is grouped into several major categories:

[Regulatory and Compliance] [Scientific]

Regulatory and Compliance Information

Scientific

Contacting Bruce G. Berger

e-mail to Bruce G. Berger
bergerbg@yahoo.com