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FDA new rule 2 articles

FDA issues new rule on labeling medication for pregnancy, breastfeeding

New guidelines have been set for how information about using medications during pregnancy and lactation is listed on prescription drugs and biological products to better communicate risks and benefits of using these medical products during pregnancy and breastfeeding. The new guidelines, established by the Food and Drug Administration (FDA) replace the decades-old product letter categories – A, B, C, D and X – that have been used to classify risks of prescription drugs during pregnancy. The new format involves three detailed subsets that describe the risks within the real-world context of caring for pregnant women who may need medication. FDA ... Read More

FDA proposes new rule to allow generic drug makers ability to update safety labels

The Food and Drug Administration (FDA) is taking steps to allow manufacturers of generic drugs permission to change safety labels when new information about potential side effects is discovered. Currently, generic drug makers are required to have the same safety labels as their brand-name counterpart. For years, citizen groups have petitioned the FDA to take measures to ease the regulations that prevent generic drug companies from providing new information about potential risks associated with their products. Brand-name drugs go through a rigorous approval process through the FDA during which they must provide data from clinical trials demonstrating the drug’s safety ... Read More