JD Supra

FDA Clarifies Labeling Expectations for Prescription Drug Use-Related Software

On September 19, 2023, the U.S. Food and Drug Administration (“FDA” or “the Agency”) published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (the “Guidance”) ...
JD Supra

U.S. FDA: labeling guidance for sponsors incorporating prescription drug use-related software

The U.S. Food and Drug Administration (FDA) published new draft guidance on “Regulatory Considerations for Prescription Drug Use-Related Software” (PDS Guidance), which describes how FDA intends to ...
WBAL

California could launch generic prescription drug label

SACRAMENTO, Calif. (AP) — California could become the first state to make its own prescription drugs under a proposal announced Thursday by Gov. Gavin Newsom, who says it would “take the power out of ...
Yahoo

Prescription drugs' fine print is important – a toxicologist explains how to decode package inserts to take medications safely and increase their effectiveness

Many adults take prescription drugs, and usage rates are continually increasing. With approximately 1.3 million emergency department visits in the U.S. caused by adverse drug events each year, patient ...
The Greeley Tribune

Bill awaiting governor’s signature creates hope for visually impaired people managing medications

Prescription labels can present difficulties among blind and visually impaired Coloradans in understanding a medication’s dosage and frequency, leading to dangerous health concerns. Colorado lawmakers ...
Medscape

Introduction to the New Prescription Drug Labeling by the Food and Drug Administration

Developing standards for the conversion of paper labeling to an electronic format is a high priority for FDA. The content and format revisions to the prescribing ...