Rep. Lauren Boebert introduces legislation to remove some barriers to the development of botanical drugs.
Five stakeholders support an FDA proposal for an expedited IND pilot program and suggest ways to improve it.
Attorneys from Arnall Golden Gregory examine and offer advice on FDAs intensified scrutiny of drug advertising, advising companies to prepare for clos...
A new report from Senate HELP chair Bill Cassidy (R-LA) targets FDA for allowing the abortion drug mifepristones Risk Evaluation and Mitigation Strate...
Akin Gump attorneys highlight major issues in the PDUFA 8 commitment letter that is now open for public comment.
MasterControl issues its 2026 life sciences regulatory readiness playbook demonstrating the significant ways in which the FDA Quality System Managemen...
The U.S. Court of Appeals for the Fifth Circuit upholds FDAs decision to remove tirzepatide from the agencys drug shortage list, a ruling that limits ...
Reed Smith attorney James Beck says courts so far have rejected all arguments citing the Supreme Courts Loper Bright decision as a reason to reject pr...
