The agency seeks to clarify potential confusion for consumers linked to label statements about the level of acetaminophen that can pose a threat. FDA proposes an alternative warning to be used on labels of some acetaminophen-containing products.
FDA proposes an alternative statement for OTC drug makers to use in a required label warning for acetaminophen-containing products to explain when the ingredient can cause severe liver damage.
In a July 3 draft guidance, the agency says it will allow some acetaminophen products to warn that...
HHS' culling of mRNA vaccine projects under BARDA will heavily impact pandemic preparedness. Tiba Biotech was even “caught off guard” by its inclusion, because its project was neither a vaccine nor mRNA-based.
The program would allow early interactions with FDA staff to speed construction and approval of pharmaceutical manufacturing facilities in the US, but will staff be available?
Quantitative estimates of the safety risks with opioid pain medication, including the risk of addiction and misuse, must be added to labeling.
A calculation used to determine whether the FDA has the staff to handle its workload also was not included in the description of prescription drug user fee calculations.
