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 how we do it. 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, the latest policies, and the Agency’s expectations. Guidance on the cGMP regulations can also be obtained through FDA’s Small Business Representatives that are located throughout the country, through FDA District Offices, and from the Center for Drug Evaluation and Research, Office of Compliance, Division of Manufacturing and Product Quality.
