• Australia Proposes Guidance on Role of Authorized Person in Drug Manufacturing Process

    Australia's Therapeutic Goods Administration has opened a new consultation on proposed guidance regarding the individual (known as the Qualified or Authorised Person) that must certify that a drug has been manufactured according to the requirements of the marketing authorization and cGMPs.  The Australian system is different from the European system of batch release by a Qualified Person, which is why the current PIC/S Guide to Good Manufacturing Practice for Med...
  • Agency Increasing Number of Supplement Inspections, Says Fabricant

    The number of inspections conducted by the US Food and Drug Administration (FDA) is increasingly rapidly as the agency moves to crack down on violators of quality regulations, the Director of FDA's supplement program said, reports Natural Products Insider . Daniel Fabricant, director of FDA's Division of Dietary Supplement Programs, said the agency is starting to use its authorities more aggressively-something Regulatory Focus took note of in April 2012 and May 2...
  • FDA 'Aghast' at Lack of cGMP, AER Compliance by Supplement Manufacturers

    The US Food and Drug Administration's (FDA) top dietary supplement regulator said at an industry conference meeting he is " aghast at the degree of non-compliance " when it comes to current good manufacturing practices (cGMPs) and adverse event reporting (AER) in the industry, reports Nutra Ingredients USA . Speaking 25 April to a meeting convened by the Natural Products Association, Daniel Fabricant, director of FDA's Dvision of Dietary Supplement Programs, said the in...