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    FDA Explains how Companies can Modify a Drug Safety Assurance Plan

    A new guidance document issued by the US Food and Drug Administration (FDA) explains the process by which pharmaceutical companies can make changes to policies intended to control the use of, and sometimes access to, potentially dangerous drugs. Background The policies, known as Risk Evaluation and Mitigation Strategies (REMS), were first created under the 2007 Food and Drug Administration Amendments Act (FDAAA) and are meant to ensure the safe use of potentially risk...
  • House Legislators Want FDA to Discuss 'Alternatives' to Generic Labeling Rule

    A large group of House Republicans is once against raising questions about the US Food and Drug Administration's development of a rule that would change the way generic drug labels are regulated, saying it has "significant questions" about the involvement of a group of trial lawyers in the process and is interested in proposing its own "alternative approaches." Interested in learning more about FDA's generic drug labeling rule? Check out our Regulatory Explainer o...
  • Regulatory Explainer: Understanding the Regulation of Generic Drug Labels

    Regulatory Focus'  ongoing series of  Regulatory Explainers  take complicated regulatory topics and make them simple enough for anyone to understand. In our latest Regulatory Explainer, we are taking a look at a new attempt by the US Food and Drug Administration (FDA) to change the way it regulates generic drug labeling and the controversy that it is causing within industry. Alright, Start From the Beginning: What's a Generic Drug? In general, most drug...
  • Opponents, Proponents of Generic Drug Labeling Rule Unleash New Arguments and Supporters

    As legislators prepare to debate the merits of a new proposal by the US Food and Drug Administration (FDA) to change the way generic drug labels are updated to reflect new safety risks, supporters on both sides of the debate are marshalling support for their arguments. Background Focus has written extensively about the proposed rule , including its legal background , initial calls by legislators for reform , FDA's early plans for a rule change , the reaction of l...