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ROCKVILLE, MD-The Food and Drug Administration (FDA) issued a draft guidance regarding the creation of an adverse reactions section of labeling for human prescription drugs and biologics.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A copy of the draft guidance can be found on the FDA's website at www.fda.gov/cder/guidance/1888dft.htm.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.
APIC Salutes 2025 Trailblazers in Infection Prevention and Control
June 18th 2025From a lifelong mentor to a rising star, the Association for Professionals in Infection Control and Epidemiology (APIC) honored leaders across the career spectrum at its 2025 Annual Conference in Phoenix, recognizing individuals who enhance patient safety through research, leadership, and daily practice.
Building Infection Prevention Capacity in the Middle East: A 7-Year Certification Success Story
June 17th 2025Despite rapid development, the Middle East faces a critical shortage of certified infection preventionists. A 7-year regional initiative has significantly boosted infection control capacity, increasing the number of certified professionals and elevating patient safety standards across health care settings.
Streamlined IFU Access Boosts Infection Control and Staff Efficiency
June 17th 2025A hospital-wide quality improvement project has transformed how staff access critical manufacturer instructions for use (IFUs), improving infection prevention compliance and saving time through a standardized, user-friendly digital system supported by unit-based training and interdepartmental collaboration.