• Feature ArticlesFeature Articles

    Challenges to contemporaneous FDA approval for companion diagnostics and their drug partners

    Ideally, the drug development pathway aligns with the companion diagnostics (CDx) validation on stages and steps in that the efficacy of the drug and CDx are clinically validated together as part of a phase 3 trial. However, the market is trending toward earlier submissions from the drug side. Specifically, if efficacy is shown in a phase 2 study, then a new drug application (NDA) or biologics license application (BLA) could be submitted using this information, especially...
  • Regulatory NewsRegulatory News

    Public Citizen Sues FDA Over Redacted Advisory Committee Info

    The consumer advocacy group Public Citizen is suing the US Food and Drug Administration (FDA) in federal court over the agency's practice of redacting information in the curricula vitae (CV) of its advisory committee members. Public Citizen alleges that the redactions mask information about these outside experts that could reveal potential biases and provide relevant background on their professional qualifications, according to a complaint filed to the US District Court ...
  • 11 New Consumer Advocates to Join Advisory Committees in 2013

    The US Food and Drug Administration (FDA) is calling for the nomination of consumer representatives for its public advisory committees. FDA uses the advisory panels to review high-risk drug products or pressing issues that warrant a transparent discussion of the issues and allow for public comment. Though regulators are free to disregard the final opinions of the committee-and occasionally do, most often when the panel is deeply divided-the committees' opinions often for...
  • FDA Calls for Nominations as 11 Spots Open on Four Advisory Committees

    US regulators are calling for the nomination of new members of several prominent advisory committees it uses to formulate non-binding but influential recommendations. The committees often serve as a pre-review stage for new or controversial products, and the views of its committee members regularly act as a barometer for safety, efficacy and quality concerns. In a Federal Register notice released 4 October, the US Food and Drug Administration (FDA) said it is aw...