• FDA: After Recall of 300M Wipes, New York Manufacturer Still Failed to Test Products

    A report issued by the US Food and Drug Administration (FDA) is faulting a New York-based company for failing to test its sterile wipe products even after recalling hundreds of millions of products due to bacterial contamination, reports The Bellingham Herald. The company, Professional Disposables Incorporated, initiated a recall in September 2011 involving 300 million alcohol pads which were supposed to be sterile but were instead contaminated with Bacillus cerus. Tha...
  • CDER Launches New Training Tool For International Regulatory Bodies

    The US Food and Drug Administration (FDA) released a new training tool to the public on 24 February for  international regulators to "learn first-hand how [the Center for Drug Evaluation and Research (CDER)] organizes the drug review process and carries out its mission of ensuring the safety and efficacy of human drug products in the US." The tool, CDER World , acts as an Internet-based "compendium of information" about how CDER operates as an agency, adapts to t...