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    New Fundamentals of US Regulatory Affairs Book Now Available

    RAPS has just published the updated, ninth edition of Fundamentals of US Regulatory Affairs , the book that has become one of the most essential references for regulatory professionals working with healthcare products for the US market. The new edition is now available  in a print, hardcover edition or as an e-book. RAPS currently is offering free shipping for the book and for all orders from the RAPS Store through 31 August. Fundamentals of US Regulatory Affa...
  • Regulatory NewsRegulatory News

    FDA Attitude on Off-Label Prescribing Central to Arizona Abortion Drug Access Case

    A federal court has ruled that Arizona's attempts to limit access to an abortion drug known as RU-486 (mifepristone) are unconstitutional, drawing on the US Food and Drug Administration's (FDA) authority to support its ruling. Background The case involved Arizona's attempts to restrict the use of RU-486, which is approved by FDA for use in terminating pregnancy within 49 days of the start of a woman's last menstrual period. As FDA explains on its website , the ...