• where experts go to learn about FDA
  • Month: August 2018

    • FDA’s IVD TA: It’s Not Just Technical AssistanceAugust 14th, 2018

      Since 1992, the Food and Drug Administration’s (FDA’s) efforts to regulate laboratory developed tests (LDTs) have been one of the most controversial device regulatory topics.  We have written about this topic multiple times (see our list at the end of this post). The focus of many …

    • ACI’s 32nd FDA Boot Camp – Boston EditionAugust 13th, 2018

      The American Conference Institute’s (“ACI’s”) popular “FDA Boot Camp” – now in its 32nd iteration – is scheduled to take place from September 26-28, 2018, at the Omni Parker House, in Boston, Massachusetts. The conference is billed as the premier event to provide folks with …

    • The Center for Food Safety Pushes AMS to Finalize BE Labeling Rule; Sues Seeking to Force AMS to ActAugust 10th, 2018

      As readers of this blog know, the Agricultural Marketing Service of the USDA (AMS) is mandated to implement the 2016 National Bioengineered Food Disclosure Standard (“NBFDS” or the “Standard”). Congress set a time line for AMS to take certain actions toward implementing the Standard.  AMS, …

    • It Feels Like the First Time: FDA’s First Competitive Generic Therapy ApprovalAugust 9th, 2018

      Well, we haven’t quite waited the lifetime that Foreigner did, but it’s exciting nonetheless. Only about one year after signing the provisions into law, FDA announced the approval of the first generic drug with a Competitive Generic Therapy (“CGT”) designation: ANDA 211067 for potassium chloride …

    • Can FDA’s Drug Shortage Task Force Devise New Solutions to an Old Problem?August 6th, 2018

      Last month, FDA announced the creation of a new Drug Shortage Task Force, intended to address continuing shortages of medically necessary drug products. The Task Force expands FDA’s existing group focused on drug shortages and, according to Commissioner Scott Gottlieb, will “delve more deeply into …

    • Americans for Homeopathy Choice Petitions FDA to Establish a Homeopathic Advisory Committee and RegulationsAugust 3rd, 2018

      As readers of this blog may recall, last year, FDA issued a draft guidance describing how FDA would prioritize enforcement and regulatory actions regarding homeopathic drug products marketed in the United States. This new guidance document, once finalized, would replace the compliance policy guide, CPG …

    • FDA Holds Nutrition Innovation Strategy Public MeetingAugust 1st, 2018

      On June 26, FDA announced a public meeting to discuss the implementation of the Nutrition Innovation Strategy (NIS), a broad initiative intended to promote public health through efforts to empower consumers to make better and more informed decisions about their diets and health, foster the …