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 ...
JD Supra

FDA Finalizes ‘Instructions for Use’ Guidance on Patient Labeling for Drugs and Biologics

As companies begin planning for the upcoming year, attorneys who sit on promotional review committees should consider the significant guidance published by the U.S. Food and Drug Administration (“FDA” ...
JD Supra

Brazil requires drug makers to add QR codes in package inserts and implement traceability systems

A new law was enacted in Brazil on May 12, 2022 (Law No. 14,338/2022) requiring that medicine package inserts will have to be provided in digital format, in addition to the existing written format.
RAPS

Brazil: New Format Package Inserts for 135 Drugs Online

Brazil's national health agency, ANVISA, has posted online new package insert leaflets with revised content, large print, and more patient friendly text for 135 drug products. The site provides ...
WRAL

FDA Hopes New Inserts Will Clear Confusion Over Prescription Drugs

Every prescription drug comes with a paper insert of information. It is required information that includes everything from clinical trial results to the drug's chemistry. Some argue that there is so ...
Los Angeles Times

FDA Revises Prescription Drug Information Inserts

WASHINGTON — The Food and Drug Administration said Wednesday that it was overhauling the inserts packaged with prescription drugs to make the information easier to understand. Officials hope that the ...