JD Supra

DTC Promotional Labeling and Advertisements: Quantitative Efficacy Wins Over FDA in Final Guidance on Presenting Risk Information

In June 2023, the U.S. Food and Drug Administration (FDA) published final guidance (Guidance) on presenting risk and efficacy information for direct-to-consumer (DTC) promotional labeling and advertisements for prescription drug and biologic products for ...
RAPS

FDA drafts guidance on drug interaction labeling

The US Food and Drug Administration (FDA) has released a new draft guidance describing what should and should not be included in the Drug Interactions (DIs) section for human prescription drug and biological product labeling as well as how drug interaction ...
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 includes revised dosing regimens and moves a boxed ...
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 product labeling regulations to require that Rx ...
RAPS

FDA Drafts Two New Guidances on Drug Labeling

The US Food and Drug Administration (FDA) on Monday released one draft guidance on the content and format of the “Drug Abuse and Dependence” section of labeling and another on the content and format of the Instructions for Use (IFU) of a medicine.
TechJuice

Government Approves Nationwide Track and Trace System for Medicines to Curb Fake Drugs

Pakistan approves a nationwide Track and Trace system for medicines to curb counterfeit drugs, improve drug safety, and enable digital verification across supply chain.