FDA

Scholar proposes reforms to address deficiencies in FDA’s premarket review powers.

Scholars propose changes to patent disclosures under the Biologics Price Competition and Innovation Act.

Mitch Zeller discusses the challenges of regulating to protect the public’s best interest.

Scholar urges lawmakers to hold multi-level marketing companies liable for misleading claims made by salespeople.

The Supreme Court offers a robust vision of hard look review in a polarized political climate.

Anna Wexler explains “do-it-yourself medicine” and how regulators can protect consumers using at-home medical therapies.

Scholar argues that FDA has the authority to regulate coverage algorithms used by health care insurers.

Scholars examine the implications of using patient-reported data in health care practice and regulation.

Marion Nestle discusses changes to agencies that would create a safer food environment.

Political pressure and wary regulators shaped FDA’s mifepristone approval in 2000.

Scholar proposes an increased focus on children’s health in food, drug, and cosmetic regulation.

Scholars debate ways to improve FDA’s accelerated approval mechanism.