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    FDA Makes it Easier to Bring Generic Copies of Dangerous Drugs to Market

    A new draft policy issued by the US Food and Drug Administration (FDA) would makes changes to a complicated safety policy in the hopes of making it easier for generic drug manufacturers to make cheaper copies of dangerous drugs. Background To understand FDA's change, you need to understand quite a bit about REMS—Risk Evaluation and Mitigation Strategies. REMS were first introduced under the 2007 Food and Drug Administration Amendments Act (FDAAA) , and were meant to e...
  • FDA Announces Meeting Intended to Start Standardization Process for REMS

    US regulators have announced they will soon hold a lengthy meeting to discuss the possibility of standardizing the format and assessment process for risk evaluation and mitigation strategies (REMS), a series of tools required of some drugs by the US Food and Drug Administration (FDA) to control the potential risks associated with use of a drug product. Background REMS were first introduced under the 2007 FDA Amendments Act (FDAAA) , and were meant to act as a regula...
  • 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...
  • FDA Looking to Develop Further REMS Guidance, Release Issue Paper

    The US Food and Drug Administration (FDA) is planning a workshop to gather feedback and information it can use to develop guidance for industry on the best practices for assessing goals associated with Risk Evaluation and Mitigation Strategy plans. The workshop, announced in a 2 May Federal Register posting, will take place on 7 June 2012. "The purpose of the public workshop is to initiate constructive dialogue and information-sharing among regulators, researchers, th...