The drug approval process and the information it provides.

  title={The drug approval process and the information it provides.},
  author={Alan C Myers and Sheila R Moore},
  journal={Drug intelligence & clinical pharmacy},
  volume={21 10},
By law, the commissioner of the Food and Drug Administration (FDA) is responsible for determining whether a new drug is safe and efficacious before it is approved for marketing in the U.S. and for monitoring its use after approval. This paper provides a brief overview of the approval process, in terms of responsibilities of the sponsor in submitting an application for review to the FDA and FDA's responsibilities and organizational procedures for reviewing and approving those applications. A… CONTINUE READING

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