FDA launches the Innovative Science and Technology Approaches for New Drugs pilot program for novel drug development tool developers.
Moderna submits an emergency use authorization for its Covid-19 vaccine mRNA-1273 based on updated efficacy data showing 94.1% vaccine efficacy.
FDA approves a Profound Medical humanitarian device exemption to market Sonalleve for treating osteoid osteoma, a non-cancerous bone tumor in the leg.
Federal Register notice: FDA extends the comment period for a 10/13 notice announcing a public meeting and requesting comments on a potential revised ...
Federal Register notice: FDA makes available a final guidance for industry #242 entitled In-Use Stability Studies and Associated Labeling Statements f...
FDA makes available a draft guidance on Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, a...
FDA Review posts the Federal Register notices for the week ending 11/27/2020.