• FDA Says 'Plan B' Ruling Overstepped Judicial Authority, Endangering Regulatory Process

    Just hours after approving an application from Teva Women's Health allowing the company to market its product over-the-counter (OTC) to women as young as 15 years of age, the US Food and Drug Administration (FDA)-by way of the US Department of Justice-filed an appeal in the US District Court of New York seeking to overturn an earlier ruling that ordered the agency to approve the drugs for girls as young as 10 years of age. Background In December 2011, Kathleen Sebelius,...
  • FDA Appeals Antibiotic Decision, Earning Congresswoman's Ire

    The US Food and Drug Administration (FDA) quietly moved to appeal a ruling by US Magistrate Judge Theodore Katz, who said the agency must either plan to withdraw its approval for most antibiotics used in animal feed or withdraw approval for their non-therapeutic applications. The agency, in conjunction with the US Department of Health and Human Services, filed an appeal with the US Second Circuit Court of Appeals in New York on 21 May. The case was originally filed by ...
  • CDER Provides Guidance to FDA Staff on How to Expedite Review of ANDA Supplements

    The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) has issued a new Manual of Policies and Procedures (MAPP) document in which the agency describes to internal staff the guidelines for expediting the review of Abbreviated New Drug Application (ANDA) supplements. FDA's 5240.1: Requests for Expedited Review of Supplements to Approved ANDAs , posted  27 April, describes how ANDA supplement sponsors "may ask FDA to expedite ...