• Shire Pulls BLA Submission After FDA Demands More Clinical Trials

    • 16 March 2012
    Biopharmaceutical manufacturer Shire withdrew its Biologics License Application (BLA) for Fabry drug Replagal (agalsidase alfa) after the US Food and Drug Administration (FDA) indicated that the company needed to conduct more clinical trials. Ireland-based Shire's withdrawal of its application on 15 March was reportedly due to the perception that FDA's demands would create a "significant delay" that would push back any possible approval of the product by years. FDA has ...
  • FDA Releases Guidance on Proper Size, Testing of Sprinkled Drug Products

    The US Food and Drug Administration (FDA) released guidance 29 February that provides the agency's current thinking about the proper size ranges and testing methods for drug products that are sprinkled in bead form. Guidance for Industry on Size of Beads in Drug Products Labeled for Sprinkle advises sponsors of new drug applications (NDAs), abbreviated new drug applications (ANDAs) and biologics licensing applications (BLAs) that: It is important to have reasonable...
  • CDER: Guidance on NDA/BLA/ANDA Data Standards Coming in Mid-2012

    The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) announced on 12 January that it is planning to release  new regulatory requirements by mid-2012 for electronic submissions of all study data included in New Drug Applications (NDAs), Biologics License Applications (BLAs) and Abbreviated New Drug Applications (ANDAs). The new regulatory requirements are a result of CDER's Data Standards Program, which is aims to create standar...