FDA Rejected Drug Application Due to Inadequate Testing in 1960
What happened
In 1960, Frances Kelsey, a pharmacologist employed by the Food and Drug Administration, reviewed an application from a major pharmaceutical manufacturer seeking approval for a sedative. Kelsey turned down the application because the testing and data provided were inadequate. The pharmaceutical company subsequently attempted to secure approval for the drug over the following year and a half.
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Why it matters
The Food and Drug Administration's review process determines which new drugs can be marketed. This regulatory function directly impacts the pharmaceutical industry's ability to bring new products to market and generate revenue.
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Who's involved
- FDARegulatory agency that reviewed the drug application
Who could feel it
Possible knock-on effectsThese are possibilities Brind reasoned out, not predictions, and not advice. Most are not stated in any report.
- FDASpeculative
The Food and Drug Administration could see changes in the volume of drug applications it reviews, affecting its operational costs.
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The entities involved
Related events
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