FDA

Will FDA Guidance Hasten Testing for COVID-19?

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

Resolving Regulatory Confusion Over Medical Software

FDA clarifies enforcement priorities for medical device clinical decision support software.

Regulation Serves People, and Depends on Them Too

Regulators and regulatory scholars alike need to keep in mind regulation’s essential human element.

FDA Announces Age Change for Tobacco Sales

Online announcement declares that new tobacco age restrictions are effective immediately.

Drug Approval During a Public Health Crisis

FDA’s approval of an Ebola vaccine can serve as a framework for drug development during other epidemics.

Smartphone

Regulating Mobile Medical Applications

As mobile medical applications continue to proliferate, regulators lack a solid framework for oversight.

Combatting Drug Shortages

A federal task force proposes regulatory solutions to mitigate drug shortages.

Lab-grown meat

Meat and Meat Alternatives Regulation

As people consume less meat and more meat alternatives, regulators have a role to play in ensuring accurate consumer information and safety.

Files

Regulating Human Subjects Research

A changing research environment means regulators and institutional review boards must adapt.

Robotic surgery

Robotic Surgeries Need Regulatory Attention

Lawyers and regulators are concerned about the lack of regulations for the use of robotic technology in surgeries.

Determining the Safety of CBD Products

FDA warns consumers that the agency has not evaluated most CBD products and cannot say they are safe.

The Problem with Regulating Combination Products

Unlike new drugs and devices, combination products may fall through the regulatory cracks.