FDCA

Restoring FDA’s Premarket Review Powers

Restoring FDA’s Premarket Review Powers

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

Multi-Level Marketing, Multi-Level Accountability

Multi-Level Marketing, Multi-Level Accountability

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

Addressing the Medical Device Safety Crisis

Addressing the Medical Device Safety Crisis

Scholar calls on FDA to prioritize public health by reforming medical device regulation.

Making Drugs Safe to Kill?

Making Drugs Safe to Kill?

Lawyer proposes a new legal framework for reviewing FDA’s refusal to regulate lethal injection drugs.

Does Cosmetics Regulation Need a Makeover?

Does Cosmetics Regulation Need a Makeover?

Scholars reflect on the need for stronger regulatory oversight of cosmetics in the United States.

Smoking Out E-Cigarettes

Smoking Out E-Cigarettes

Scholars examine the regulation of electronic cigarettes and their impact on public health.

Strengthening the Stem Cell Industry Through Better Regulation

Strengthening the Stem Cell Industry Through Better Regulation

FDA should take steps to strengthen the regenerative medicine industry.

Calls for Regulatory Approval of Edible Insects

Calls for Regulatory Approval of Edible Insects

Edible insects may become essential in the wake of the COVID-19 crisis, but FDA regulation is lacking.

Encouraging Competition Through Generic Drugs

Encouraging Competition Through Generic Drugs

FDA clarifies its generic drug approval process in an effort to encourage market competition.

Obligation Alleviation During the COVID-19 Crisis

Obligation Alleviation During the COVID-19 Crisis

The most surprising regulatory dimension of the coronavirus crisis may center on the lifting of rules.

FDA Versus Our Own Stem Cells

FDA Versus Our Own Stem Cells

The federal government seeks authority over stem cell treatments but risks thwarting medical advancement.

Will FDA Guidance Hasten Testing for COVID-19?

Will FDA Guidance Hasten Testing for COVID-19?

In the face of a massive viral outbreak, a federal regulator issues unprecedented guidance on validating COVID-19 testing.