FDA to Require Medical Device ID Numbers
New agency rule designed to help identify faulty medical devices.
Learning from the FDA’s Plan B Fiasco
Plan B episode calls for reconsidering the scope of judicial review and the role of politics in rulemaking.
The FDA Trans Fats Ban and the Goal of Informed Consumers
FDA seeks comment on its determination trans fats are unsafe and should be banned.
FDA Moves to Address Drug Shortages
Agency hopes a strategic plan and proposed rule will protect patients from delayed treatment.
House Bill Would Limit FDA Oversight of Health Apps
Supporters of legislation argue FDA will not cabin its regulatory power on its own.
Week in Review
DOJ reaches tentative settlement with JPMorgan, Obama nominates head of Court of Federal Claims, and more…
Indian Supreme Court Demands Regulation of Clinical Trials
Court asks government to protect vulnerable people from poorly-run trials.
Hold the Phone: FDA to Regulate Smartphone Health Apps?
As mobile health industry grows, regulation looms.
Week in Review
GAO report finds USDA needs better data on certain procedures, OSHA publishes proposed silica rule, and more…
FDA Clarifies the Orphan Drug Act
FDA regulation seeks to encourage development of drugs for rare diseases.