11 June 2019 - In 2010, the FDA issued draft recommendations on increasing the transparency of the FDA’s processes and about expanding disclosure of information while protecting companies’ trade secrets. Among the FDA’s recommendations was that applications for new products be publicly disclosed at the time of the filing.

To date, however, regulations have not been updated to allow the FDA to publicly disclose filings for new drugs, biologics, or biosimilars. In fact, the FDA rarely asks for the public disclosure of information outside of convened advisory committees that discuss individual product applications.

This month, a research letter appearing in JAMA Internal Medicine raises the questions of whether regulatory filings for new products are already made publicly available despite the FDA’s stance of treating these applications as confidential and whether there is room for increased transparency from the agency.

Read Center for Biosimilars article