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Vaccines are credited with reducing or effectively eradicating a number of infectious diseases such as smallpox, measles, and diphtheria. Particularly in nations like the United States, where a large number of infectious diseases were prevalent, vaccines proved to be timely interventions. The approval procedure for vaccines in the United States is regulated by the Center for Biologics Evaluation and Research. Vaccine development is often found to be demanding and requires astute knowledge and understanding of recent developments by physicians and researchers to ensure that effective vaccines are made available to the masses with minimum risk. This article aims to illustrate the regulatory scenario with regards to vaccine development and licensure in the United States with a brief look at the origin of vaccines and their regulations in the nation. Also, it details the challenges faced by the United States vaccine industry to remain relevant in today's constantly evolving world.

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