FDA Labeling System for Drugs in Pregnancy

摘要: OBJECTIVE:To review the current Food and Drug Administration (FDA) pregnancy labeling system, examine new FDA-proposed system for form content, provide comments on its suitability implementation.DATA SOURCES:Data were obtained from FDA's Web site (www.fda.gov), PubMed, Federal Register, LexisNexis, Physician's Desk Reference (PDR), Drugdex, Current Contents.STUDY SELECTION:Research articles involving drugs pregnancy, lactation, subcommittee meeting of FDA included.DATA EXTRACTION:Prospective, case-control studies registries.DATA SYNTHESIS:Currently, only 40% in PDR have categories listed. The medical profession has resorted to other means assess risk, such as retrospective chart review, case reports, consultation with experts regional drug information centers.CONCLUSIONS:The proposed strives more clinical usefulness by reliance human ...