The Food and Drug Administration, together with its European and Australian counterparts, has released two reports detailing the results of pilot programs focused on increasing international regulatory collaboration among the agencies so that drug quality and safety can be enhanced globally. The report on the Good Clinical Practice (GCP) initiative details the success of information-sharing and collaboration on inspections relating to clinical trials; and the report on the Active Pharmaceutical Ingredients initiative details the success of information-sharing among the FDA, Australia’s Therapeutic Goods Administration and for Europe, the European Medicines Agency (EMA), France, Germany, Ireland, Italy, the United Kingdom and European Directorate for the Quality of Medicines & Healthcare (EDQM).
The Food and Drug Administration is reopening the comment period on its 2007 proposed rule on the “gluten-free” labeling of foods, in which FDA proposed to define the term “gluten-free,” for voluntary use in the labeling of foods, to mean that the food does not contain an ingredient that is any species of wheat, rye, barley, or a crossbred hybrid of these grains, wheat flour, or wheat starch, if the use of that ingredient results in the presence of 20 parts per million or more gluten in the food; or 20 ppm or more gluten. FDA is reopening the comment period for the proposed rule to solicit comments on a report, “Health Hazard Assessment for Effects of Gluten Exposure in Individuals with Celiac Disease: Determination of Tolerable Daily Intake Levels and Levels of Concern for Gluten," among other things. Comments are due by October 3, 2011. FDA press release available here.
On August 1, 2011, the Food and Drug Administration posted a revised version of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration is announcing a publication containing modifications it is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication, entitled "Modifications to the List of Recognized Standards, Recognition List Number: 027" (Recognition List Number: 027), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
On July 29, 2011, the Food and Drug Administration posted a revised version of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration is seeking comments by October 17, 2011 that will be used to formulate a proposed set of guidelines in consideration of the burden of fee amounts on small business, as set forth in the FDA Food Safety Modernization Act (FSMA). FSMA provides the Agency with authority to assess and collect user fees, including those for costs associated with certain domestic and foreign facility reinspections, failure to comply with a recall order, and importer reinspections. The Agency is seeking public comment on what burdens these fees impose on small business, how small businesses should be defined, and whether and how the Agency should alleviate such burdens.
On July 27, 2011, the Environmental Protection Agency's ENERGY STAR program announced the top contenders at the midpoint of the 2011 National Building Competition, in which the building with the largest percentage reduction in energy use will be recognized as a winner in November 2011. The list of top contenders identifies 12 organizations with the greatest percent reduction of energy use. Of the 12 top contenders, there was one retail store, Office Depot, which had a 17% reduction in energy use.
On July 27, 2011, the Food and Drug Administration posted a revised version of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration has issued draft guidance that clarifies the kinds of changes or modifications to a previously cleared 510(k) device that trigger the need for a new premarket submission, such as changes regarding labeling, the technology used in the device, performance specifications, manufacturing changes, etc. To legally market a device, manufacturers must submit a premarket notification or 510(k) demonstrating that a new or modified product is substantially equivalent to another legally marketed medical device. When manufacturers make changes or modifications to a device after FDA clearance that could significantly affect the product’s safety or effectiveness or constitute a major change to the intended use of the device, another 510(k) must be submitted.
The Food and Drug Administration's Office of Food Safety is seeking comments on proposed draft revisions to the "Principles for the Establishment and Application of Microbiological Criteria (MC) for Foods," which the working group of the Codex Committee on Food Hygiene is considering. Comments are due September 15, 2011. Copy of the proposed revision is available by emailing documents@brokerpower.com.