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    FDA Scraps Pregnancy Labeling Classification System in Favor of New Standard

    The labeling on many prescription drug products approved after 2001 will need to be reconfigured to include clearer information about whether a drug is safe to use during pregnancy, the US Food and Drug Administration (FDA) announced today. Background Prescription drug labeling has been subject to standardization measures in the US since 1979, when measures to introduce labeling uniformity were first passed. Those measures were substantially updated in 2006 under FDA's ...
  • FDA Plans to Review REMS, ETASU Strategies for Teratogenic Products

    The US Food and Drug Administration's (FDA) Drug Safety and Risk Management Advisory Committee (DSaRM) is preparing to meet in December to discuss risk management strategies for teratogenic products. Teratogens are most commonly pharmaceutical products which, when taken by a pregnant woman, can cause birth defects or other developmental abnormalities. One of the most notorious teratogens is Thalidomide, a drug used briefly in the 1950s and 60s to treat the effects of mor...
  • South Korea Scrambles to Strengthen Import Controls as Capsules Seized Containing Human Flesh

    South Korea is moving to quickly strengthen its import controls after encountering repeated attempts to smuggle in drug products containing the powdered remains of deceased human flesh, reports The Korea Times . "The Korea Customs Service (KCS) said it apprehended 29 smugglers, who disguising themselves as tourists and attempted to bring some 11,000 capsules into Korea in their luggage," wrote The Korea Times . "Six people used international parcels to smuggle in the m...