In late September, the Food and Drug Administration (FDA) released a draft guidance on benefit-risk assessments for drugs and biological products. The draft guidance includes considerations the agency uses when weighing the...more
On August 23, 2021, the Food and Drug Administration released the PDUFA VII commitment letter, which contains the agency’s performance goals for the five-year window (Fiscal Year 2023 to 2027) covered by the next iteration of...more
Background -
Amid the stalemate surrounding a new COVID-19 response bill, Senate Republicans are circulating a new COVID-19 stimulus package that they intend to serve as their response to the House Democrats’ $25 billion...more
On November 7, the U.S. Food and Drug Administration (FDA) announced the launch of the MyStudies app, the latest in a series of concrete activities to drive the integration of the patient voice in clinical trials and the drug...more