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ROCKVILLE, MD-The Food and Drug Administration (FDA) issued a draft guidance regarding the creation of an adverse reactions section of labeling for human prescription drugs and biologics.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A copy of the draft guidance can be found on the FDA's website at www.fda.gov/cder/guidance/1888dft.htm.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.
Second Strain of Bird Flu Found in US Dairy Cows: What It Means for Infection Prevention and Control
February 7th 2025A new H5N1 strain was found in Nevada dairy cows, challenging earlier transmission theories. This raises concerns about animal vulnerability, human health risks, and food safety. Experts emphasize the need for improved surveillance, biosecurity, and cross-sector collaboration to contain the virus spread.
Fungal Infections: The Silent Epidemic Threatening Global Health
February 6th 2025Fungal infections are a rising global threat, with antifungal resistance complicating treatment. Neil J. Clancy, MD, emphasizes the urgent need for research, better diagnostics, and stronger infection prevention strategies.