Amendments to pregnancy labeling
A proposed rule to alter labeling concerning the use of prescription drugs in pregnancy is under review of the White House Office of Management and Budget as of Jan. 3. The proposal, titled "Content and Format of Labeling for Human Prescription Drugs and Biologics: Requirements for Pregnancy and Lactation Labeling," would revise labeling due to concerns expressed by stakeholders at a public hearing, in focus groups, and in several advisory committee meetings that the letter categories (A, B, C, D, X) currently used to characterize the risk to the fetus of using the drug during pregnancy are confusing, overly simplistic and not adequate to communicate risks effectively...
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A proposed regulation on the format and content of drug labeling to address pregnancy and lactation issues could be published this month, according to the HHS Semiannual Regulatory Agenda. Published in the May 5 Federal Register, the agenda sets a May 2008 target date for the proposed rule, which is intended to convey more clearly the risks to a fetus or newborn from a mother's use of a drug (1"The Pink Sheet," Jan. 7, 2008, In Brief)
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