People who do not follow the activities of the US Food and Drug Administration (FDA) closely might be surprised to learn that the agency does not publicly disclose applications for new drugs and therapeutic biologics. The applicants may publicly disclose their applications, such as in press releases or in filings with the Securities and Exchange Commission (SEC), and usually do. The FDA, however, with limited exceptions, does not disclose any information, even about the existence of an application, until—and if—a new medical product is approved. A notable exception is when the FDA asks an advisory committee to discuss an application.
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Steinbrook R. Increasing Transparency at the US Food and Drug Administration. JAMA Intern Med. 2019;179(8):1146–1147. doi:10.1001/jamainternmed.2019.1194
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