• where experts go to learn about FDA
  • Month: June 2019

    • Go for It! (Connect) Paragraph IV! FDA Revamps ANDA Paragraph IV Certifications ListJune 19th, 2019

      The Paragraph IV certification list on FDA’s website is a very useful tool for generic drug manufacturers in evaluating the potential for 180 day exclusivity for any given product. The list generally describes drug products for which one or more substantially complete ANDA containing a paragraph …

    • APHIS Proposes a More Hands-off Approach for Genetically Engineered PlantsJune 13th, 2019

      On June 5, 2019, the Animal Plant Health Inspection Service of the USDA (APHIS) announced the availability of a proposed rule titled “Movement of Certain Genetically Engineered Organisms.”  The proposed rule was published on June 6, 2019.  On June 7, the 449 pages long draft environmental …

    • NOP Clarifies Requirement for Land Underlying Organic Crop Container SystemsJune 10th, 2019

      On June 3, 2019, the Agricultural Marketing Service (AMS) announcedthat the National Organic Program (NOP) published a letter to certifiers titled, “Certification of Organic Crop Container Systems.” Over the last decade, there has been a disagreement within the organic industry about use of container systems in …

    • FDA Issues Guidance for Industry: “Section 503A Bulks List Final Rule Questions and Answers”: The Saga Continues….June 7th, 2019

      The U.S. Food and Drug Administration (FDA) recently issued a guidance document that intends to “help small businesses better understand and comply” with the Agency’s Section 503A bulk substances final rule, issued February 19, 2019.  The final rule establishes FDA’s criteria for evaluating nominated bulk …

    • FDA Encourages Food Industry to Use “Best if Used by” date for Shelf-Stable FoodsJune 4th, 2019

      In recent years, food waste has received increasing attention.  Based on studies, it appears that up to 40 percent of the food in the United States is never eaten.  Waste occurs at every step in the food production and consumption chain.  However, data suggest that …

    • ACI’s Annual Legal, Regulatory & Compliance Forum on Dietary SupplementsJune 3rd, 2019

      The American Conference Institute (“ACI”), together with the Council for Responsible Nutrition, are sponsoring ACI’s  Annual Legal, Regulatory, and Compliance Forum on Dietary Supplements. The conference is scheduled to take place at the InterContinental New York Times Square in New York, New York from June …

    • Join Our Team: HPM Seeks Junior to Mid-Level AssociateJune 3rd, 2019

      Hyman, Phelps & McNamara, P.C., the nation’s largest boutique food and drug regulatory law firm, seeks a junior to mid-level associate.  A demonstrated interest in food and drug law and regulation is preferred; strong research and writing skills are required.  Compensation is competitive and commensurate …

    • The BLOCKING Act: “Oh You Know, Strikes and Gutters, Ups and Downs”June 3rd, 2019

      That quote from “the Dude” from one of the final scenes of the 1998 film The Big Lebowski sums up well where things stand—or should we say “cannot stand, man”—insofar as drug pricing legislation, and, in particular, the Bringing Low-cost Options and Competition while Keeping …