Vaccines--why the US government must act.
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Biomedical subjects
Publications and source records attributed to Henry I Miller.
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Explore the source record for details and available documents.
Explore the source record for details and available documents.
Explore the source record for details and available documents.
Explore the source record for details and available documents.
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Since the current system for the regulation of drugs in the United States was established in 1962, the FDA has steadily increased the scope of its responsibilities and activities, and, concomitantly, the regulatory burden on drug developers. The costs and time that are required for drug development have spiralled upwards. Reform of drug regulation is necessary; it must be fundamental in nature, and it must come from outside the agency through new legislation.
Biotechnology applied to pharmaceuticals has made significant contributions to medicine during the past 20 years. Although important products will continue to emerge, benefiting patients and perhaps lowering medical costs, there are too many biopharmaceutical companies chasing too few products, which are themselves over-regulated and incredibly expensive to test and bring to market.