A response to strategy #2: streamlining the regulatory process.

Glezen, W Paul · Clin Infect Dis · 2006

editorial · Level V

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Abstract

Regulatory burden has contributed to the decline in the production of vaccines in the United States. Production of influenza virus vaccine is perilously limited at a critical period when vulnerable populations are increasing and the threat of a pandemic is looming. Regulatory bodies must work with manufacturers to facilitate implementation of new production practices, to ensure steady expansion of the supply of safe and effective vaccines.

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