U.S. Food and Drug Administration
How would a new drug company learn about CGMPs and about FDA’s expectations on complying with them?
FDA publishes regulations and guidance documents for industry in the Federal Register. This is how the federal government notifies the public of what we are doing and why. FDA’s website, www.fda.gov also contains links to the CGMP regulations, guidance documents, and various resources to help drug companies comply with the law. FDA also conducts extensive public outreach through presentations at national and international meetings and conferences, to discuss and explain the CGMP requirements and the latest policy documents.