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U.S. Department of Health and Human Services

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This Week In FDA History - July 24, 1955

Photo with caption
  Medical officer Alexander Fleming reviews a New Drug Application at FDA headquarters in the early 1990s. The sheer volume of paper on these shelves, holding a single NDA, illustrates the amount of data to be reviewed in the approval process.
July 24, 1955:
FDA announced today that New Drug Application number 10,000 became effective today, "a milestone of medical progress" marking a period of rapidly evolving therapeutics, according to Commissioner George P. Larrick. Chatham Pharmaceuticals of Newark, N. J., filed the first NDA on August 31, 1938, for a hemostatic agent called Koagamin. The 10,000th one was for Abbott Laboratories' Tenserina, a reserpine formulation used in the treatment of hypertension.
FDA in 2006

The FDA began work in the 1990s to develop standards for the exchange of electronic information critical to the agency's mission. This recognized both the inefficiency of paper for transferring mass quantities of data and the need to develop a harmonized format that FDA could use, along
with its counterparts in the European Union and Japan. Consequently, firms are now able to submit paperless product applications and related material to world regulatory agencies more efficiently, while each review authority maintains its own high standards for product evaluation.