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    • Ten Years On, FDA Still Has Not Eased The Medical Device Reporting Regulatory Burden As Directed by Congress February 28th, 2017

      Ten years ago, Congress commanded FDA to ease the burden of Medical Device Reporting (MDR) for most class I and class II devices. Four years ago, we blogged about it here. FDA still has not gotten it done. Specifically, Section 227 of the Food and Drug …

    • ACI’s 29th FDA Boot CampFebruary 28th, 2017

      The American Conference Institute’s (“ACI”) popular FDA Boot Camp, now in its 29th iteration, is back in New York at the Millennium Broadway Hotel on March 22-24, 2017. The conference is billed as the premier event to provide folks with a roadmap to navigate the …

    • FDA Meeting to Discuss the Meaning and Use of the Term “Healthy” for FoodsFebruary 27th, 2017

      On February 15, FDA announced a public meeting to give interested persons an opportunity to discuss the use of the term “healthy” in the labeling of human food. As described in previous blog posts, since FDA’s issuance of a warning letter to Kind LLC in March of …

    • Drug Debarment Actions: BewareFebruary 26th, 2017

      FDA recently released a report summarizing its enforcement activities for FY 2016 (October 1, 2015 to September 30, 2016). It shows, among other things, that the number of warning letters from the Center for Drug Evaluation and Research doubled (76 in FY 2015 to 151 …

    • Hemp Industries Association Seeks Contempt against DEA; Alleges Violation of 2004 Hemp OrderFebruary 23rd, 2017

      Last month we reported that the Hemp Industries Association (“HIA”) petitioned the U.S. Court of Appeals for the Ninth Circuit to block the Drug Enforcement Administration’s (“DEA’s”) implementation of its recent final rule on marijuana extracts. On February 6, 2017, HIA filed another action with …

    • DEA Administrative Decisions Update: (Un)official Notice RevisitedFebruary 22nd, 2017

      A few months ago, we blogged on the DEA Acting Administrator’s use of official notice in final orders. Specifically, we questioned the Acting Administrator’s recent practice of relying on facts outside of the record (typically publically available state pharmacy board records) without taking official notice …

    • FDA Defines the Scope of 3-Year Exclusivity for MORPHABOND After Wrestling With Different ApproachesFebruary 21st, 2017

      It was just a couple of weeks ago that we published a post titled “Abuse-Deterrence and 3-Year Exclusivity: FDA Decisions Further Elucidate Scope and a ‘Route of Abuse’ Approach to Exclusivity.” Among other things, we discussed Egalet US, Inc.’s ARYMO ER (morphine sulfate) Extended-release Tablets, …

    • Do President Trump’s Regulatory Freeze-Out and “1-in-2-Out” Orders Affect the Regulation of Compounding?February 20th, 2017

      On Inauguration Day (January 20, 2017) President Trump’s assistant Reince Priebus circulated a regulatory “freeze order” blogged here affecting regulations and guidance published in the Federal Register but that had not yet taken effect, postponing their effective date for 60 days (from January 20, 2017). The …

    • The Problem of the “Intended Use” Regulations Continues to FesterFebruary 19th, 2017

      In 2015, FDA proposed revising the so-called intended use regulation (21 CFR 201.128; id. § 801.4) to remove the famous “knowledge” sentence: “But if a manufacturer knows, or has knowledge of facts that would give him notice, that a [drug or device] introduced into interstate commerce …

    • Amgen and the BPCIA Patent Dance – ReduxFebruary 19th, 2017

      2017 is already shaping up to be a big year in court for Amgen and the Biologics Price Competition and Innovation Act (“BPCIA”). As regular readers know, Amgen’s challenge to Sandoz’s refusal to participate in the patent dance after filing of an aBLA relying on …

    • The Final Common Rule: Much Either Retained or Removed, But Not Much New AddedFebruary 17th, 2017

      On January 18, 2017, the U.S. Department of Health and Human Services along with 15 other federal agencies issued the Final Rule to revise the Federal Policy for the Protection of Human Subjects, known as the “Common Rule.”  This 1991 set of regulations created a …

    • DEA Administrative Hearings Update: Rethinking DEA’s Summary Disposition Power in “Loss of State Authority” CasesFebruary 15th, 2017

      DEA’s administrative docket is off to a quiet start this year. Since January, the Administrator has issued five final orders, all of which are so-called “loss of state authority” cases. In these cases, the Administrator adjudicates, as a matter of law, that a practitioner’s DEA …

    • Field Alert Reports – A Brief OverviewFebruary 14th, 2017

      FDA’s Field Alert Report (or FARs) reporting requirements are authorized under 505(k) of the Federal Food, Drug, and Cosmetic Act. The requirements have been in effect since the agency promulgated the regulatory provision at 21 CFR 314.81(b)(i) in 1985. The regulatory provision states, in part, …

    • FDA’s Draft Guidance on Listeria monocytogenes (In Case You Missed It)February 14th, 2017

      Just a few days before the presidential inauguration, FDA published a revised draft guidance on control of Listeria monocytogenes (Lm) in ready-to-eat (RTE) foods.  The significance of the guidance to the food sector is difficult to overstate.  Since FDA published the original draft guidance in February …

    • Rare Basis for False Claims Act SettlementFebruary 12th, 2017

      It has become almost commonplace to see a weekly announcement of a False Claims Act settlement by a major pharmaceutical or medical device manufacturer. Perhaps that is why last month’s settlement by Baxter Healthcare Corporation flew under the radar of the FCA bar.  Or perhaps …