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On September 19, 2023, the U.S. Food and Drug Administration (“FDA” or “the Agency”) published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (the “Guidance”) ...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

The FDA Approves Labeling Update for Sandoz in the Treatment of B-Cell CLL

Project Renewal updates older oncology drug labels to ensure clinical relevance and scientific accuracy, involving external experts and early-career scientists. Fludarabine phosphate's updated label ...
JD Supra

FDA proposes mandatory patient labeling for Rx drugs - Proposed Patient Medication Information (PMI) is the latest in many efforts by FDA to mandate patient-directed labeling

Last week, the U.S. Food and Drug Administration (FDA) published the proposed rule “Medication Guides: Patient Medication Information,” which would significantly change the agency’s prescription drug ...
EurekAlert!

ObesityWeek® research on Nov. 3 demonstrates gaps in drug labeling for people with obesity

SAN ANTONIO, Tx - Cancer patients need a lot of drugs—immunotherapies, chemotherapies, and anti-infectives. But new research at ObesityWeek® on Nov. 3, 2024, shows clinicians may not have all the ...