Prescription Drug Labels May Get a New Look

Article

Adverse Reaction Section Proposed

ROCKVILLE, MD-The Food and Drug Administration (FDA) issued a draft guidance regarding the creation of an adverse reactions section of labeling for human prescription drugs and biologics. The goal is to make labeling more consistent and helpful to prescribers and patients. By establishing a comprehensible format, the FDA hopes prescribers will be able to absorb the most critical drug safety information easily when reading the drug label. Format guidance divides the labeling into two subsections: an overview section that highlights the most serious, commonly occurring adverse reactions; and an in-depth section detailing adverse reaction data collected from clinical trials. The draft also suggests that the section be limited to information that can be helpful in treating, monitoring, and advising patients.

A copy of the draft guidance can be found on the FDA's website at www.fda.gov/cder/guidance/1888dft.htm. No action will be taken on the new section until after a 90-day comment period. After that time, the FDA will issue a final guidance on the matter.

Recent Videos
Pathogen Playbook Presenter: Sharon Ward-Fore, BS, MS, MT(ASCP), CIC, FAPIC
Mark Wiencek, PhD
Rebecca Crapanzano-Sigafoos, DrPH, CIC, AL-CIP, FAPIC
The CDC’s updated hospital respiratory reporting requirement has added new layers of responsibility for infection preventionists. Karen Jones, MPH, RN, CIC, FAPIC, clinical program manager at Wolters Kluwer, breaks down what it means and how IPs can adapt.
Studying for the CIC using a digital tablet and computer (Adobe Stock 335828989 by NIKCOA)
Infection Control Today's Conversations with the HSPA President, Arlene Bush, CRCST, CER, CIS, SME, DSMD, CRMST
Infection Control Today's Conversations with the HSPA President, Arlene Bush, CRCST, CER, CIS, SME, DSMD, CRMST
Cheron Rojo, BS, FCS, CHL,  CER, CFER, CRCST
Matthias Tschoerner, Dr Sc
Standardizing Cleaning and Disinfection
Related Content