Issue Date: December 1, 2011
Issued by: Center for Biologics Evaluation and Research
Topic(s): Vaccines
Status: Final
General Principles for the Development of Vaccines to Protect Against Global Infectious Diseases: Guidance for Industry
In this guidance, we, FDA (or the Agency), provide information to assist sponsors in developing vaccines to protect against global infectious diseases. The guidance will focus on development and licensure of vaccines targeted against infectious diseases or conditions endemic in areas outside the United States (U.S.). In addition, the guidance will clarify regulations, statutes and guidances applicable to the development of these products.
Download the Guidance Document
