BIO Sends Letter to HHS Secretary Alex Azar Urging him to Release Pending Vaccine Clinical Trial Guidance
October 2, 2020
On behalf of the scientists and researchers the Biotechnology Innovation Organization (BIO) represents, I am writing to request that you publicly release all new guidance developed by the Food and Drug Administration (FDA) concerning emergency use authorization for vaccines to prevent the spread of COVID-19. The release of FDA guidance would provide scientists and researchers greater regulatory clarity and strengthen public confidence in any future vaccine that may be authorized or approved.
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments regarding the request and comments on the Advanced Manufacturing Technologies Designation Program Draft Guidance.
The Biotechnology Innovation Organization thanks the Food and Drug Administration for the opportunity to submit comments regarding the request for information and comments on the Food and Drug Administration's Draft Report and Plan on Best Practices…
Following the FDA Workshop to Enhance Clinical Study Diversity on November 29-30, 2023, BIO submits specific comments per the request for information (FDA-2023-N-2462).
On behalf of the scientists and researchers the Biotechnology Innovation Organization (BIO) represents, I am writing to request that you publicly release all new guidance developed by the Food and Drug Administration (FDA) concerning emergency use authorization for vaccines to prevent the spread of COVID-19. The release of FDA guidance would provide scientists and researchers greater regulatory clarity and strengthen public confidence in any future vaccine that may be authorized or approved.