Attorney Dara Levy predicts increased FDA enforcement involving so-called native advertising and other new promotional trends.
The International Council on Harmonization publishes its Model-Informed Drug Development Discussion Group roadmap for future guidelines.
The House Energy and Commerce Committee releases a comprehensive legislative package to reauthorize FDA user fee agreements and enhance accelerated ap...
FDA posts a revised final guidance entitled Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions Durin...
Sens. Hassan and Braun call on FDA commissioner Robert Califf to quickly lead a revision of opioid drug labeling.
FDA removes a clinical hold on Pfizers giroctocogene fitelparvovec (Hemophilia A gene therapy); the company plans to resume dosing in its AFFINE trial...
FDA proposes issuing a second Section 518(b) order against Philips Respironics, this time to require the company to submit a plan to repair, replace, ...
Two CDER executives discuss misconceptions that remain about the meaning and use of real-world data and real-world evidence.