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Industry/Licensing

Licensing

New vaccine candidates are reviewed by the FDA’s Center for Biologics Evaluation and Research (CBER).  CBER reviews applications for licensure of vaccines, evaluates the manufacturers that produce these products, and enforces compliance with these standards.  Additional guidance and information about licensing can be found on the CBER website.

See also,

FDA guidelines

IND Guidance

The Prescription Drug User Fee Act (PDUFA)

The FDA Modernization ACT (FDAMA)

Vaccine Financing

Childhood vaccination in the United States, including vaccine purchase, distribution, and administration, occurs via a collaboration of public and private efforts. Approximately 56 percent of all childhood vaccine is purchased with public dollars, including federal, state and local funds; the remaining vaccine is purchased privately. The majority of publicly-purchased vaccine is distributed to and administered by health care professionals in the private sector. Privately purchased vaccine is administered almost exclusively within the private sector.

The Vaccines for Children, or VFC, program buys vaccines for children in certain groups who can't afford to buy vaccines.  Doctors can get these vaccines for their patients who qualify by joining the VFC program in their state.

Last revised: January 2, 2004

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