JD Supra

Drug Use-Related Software Back in the Spotlight at the U.S. Food and Drug Administration

In late September 2023, the U.S. Food and Drug Administration (FDA) released a draft guidance on “Regulatory Considerations for Prescription Drug Use-Related Software.” This guidance expands on (and ...
JD Supra

FDA and Prescription Drug Use Related Software – FDA’s Draft PDURS Guidance Answers Years-Old Questions and Introduces New Ones

FDA’s recent draft guidance, Regulatory Considerations for Prescription Drug Use Related Software, proposes a regulatory framework for software disseminated by a drug sponsor that supplements or ...

New White House drug abuse strategy floats wastewater testing, AI, more treatment

The Trump administration is proposing wastewater testing to try to ferret out data on illegal drug use in real time, according to a draft of a new drug control strategy obtained by CBS News. It also ...