Brenda Sandburg

Latest From Brenda Sandburg
How To Choose A Proprietary Rx Drug Name
US FDA final guidance describes possible study design to test whether selected names may misbrand a drug. Agency also okays use of two-letter USAN stems in product names and clarifies use of modifiers.
Pandemic Accelerates US FDA’s Use Of Real-World Data From Clinical Trial Design To Supply Chain
FDA’s Amy Abernethy describes how agency’s use of real-world data has evolved in response to COVID-19 and the ‘a-ha’ moment of leveraging different data sources to understand the coronavirus. Takeda R&D President Andrew Plump notes difficulties with platform trials and limitations on data sharing.
Woodcock Faces Maze Of Rules To Become Commissioner Nominee
If Biden administration wants to nominate the acting commissioner, Vacancies Reform Act would dictate the timing. Woodcock can still get the nod and remain head of the agency during the confirmation process, just as Andrew von Eschenbach retained his acting title following his nomination in 2006.
FTC Commissioner Changes Could Impact Pharma Mergers, Scrutiny Of Biosimilars Uptake
President Biden’s picks to fill two commissioner posts may shift dynamics on pharmaceutical industry enforcement. Rohit Chopra’s nomination to Consumer Financial Protection Bureau removes strong critic of pharma mergers.
A Visual Guide To How FDA Can Manage The Pandemic
Our infographic illustrates the recommendations in FDA’s COVID-19 pandemic recovery and preparedness plan, ranging from strengthening the EUA process to managing the backlog of pending inspections.
Permanent Vaccine Facility Should Be On Standby For Future Pandemics, Moncef Slaoui Says
Operation Warp Speed confirmed the necessity of having a facility on hand to develop and manufacture a vaccine for the next crisis, the outgoing advisor says.