FDA

FDA Moves to Address Drug Shortages

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

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

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

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?

Hold the Phone: FDA to Regulate Smartphone Health Apps?

As mobile health industry grows, regulation looms.

The Future of E-Cigarette Regulation

The Future of E-Cigarette Regulation

FDA plans to regulate devices as “tobacco products.”

Week in Review

Week in Review

GAO report finds USDA needs better data on certain procedures, OSHA publishes proposed silica rule, and more…

Does Regulation Work?

Does Regulation Work?

Better tools are needed to evaluate regulatory effectiveness.

FDA Clarifies the Orphan Drug Act

FDA Clarifies the Orphan Drug Act

FDA regulation seeks to encourage development of drugs for rare diseases.

Health Care Reform Goes Back to Court

Health Care Reform Goes Back to Court

Lawsuits challenge the implementation of Obamacare.

What Should the New OIRA Administrator Do?

What Should the New OIRA Administrator Do?

Now that Howard Shelanski is confirmed, he faces choices about his priorities.

Transforming the Nature of Drug Safety Regulation

Transforming the Nature of Drug Safety Regulation

Using retrospective drug safety data can improve patient care.