By Deborah L. Livornese — FDA issued another COVID-related guidance for immediate implementation last week.  Citing a substantial increase in the number of requests for individual patient expanded access requests for COVID-19 investigational drugs (which we will use here to include biological products), on June 2, 2020, FDA released a guidance for investigational review boards (IRBs)  and clinical investigators entitled “Institutional Review Board (IRB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During… [read post]

Pro Publica – “Brands have long been able to bid for the premier slot at the top left of Amazon’s listings, but during the pandemic the online retailer has begun using this position for its private-label items, raising antitrust concerns. Although customers don’t necessarily realize it, brands have for years been able to bid on search terms to secure the most visible listing positions at the top of Amazon’s product search results pages, where their products carry a “sponsored” tag above the description. Now, they still bid for top-row… [read post]

Gizmodo: “With states across the U.S. beginning to relax distancing restrictions related to covid-19, plenty of people are probably questioning whether they should get back to normal activities, including scheduling non-urgent medical appointments like physicals and teeth cleanings. So let’s talk about it. In truth, any outing that puts you in close contact with other people also puts you at risk of catching the coronavirus, so this is really about weighing the risks and benefits of getting routine medical care. But that ever-present risk doesn’t mean you… [read post]

... say what you like. Photo taken at 5:20 this morning. The "actual" sunrise time was 5:18, but the sun broke over the shoreline at 5:20.And here's the Althouse Portal to Amazon. I appreciate it when you use it. Thanks! [read post]

Today the Supreme Court issued a unanimous decision in Lomax v. Ortiz-Marquez. Justice Kagan’s opinion begins: To help staunch a “flood of nonmeritorious” prisoner litigation, the Prison Litigation Reform Act of 1995 (PLRA) established what has become known as the... [read post]

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“John Couriel, New Florida Supreme Court Justice, Centered His Life Around Public Service; Those who know Florida Supreme Court Justice John D. Couriel expect him to excel in his new role”: Michael A. Mora of the Daily Business Review has this report. [read post]

June 8, 2020 —  Herman Law, P.A. is proud to announce that Attorney Ron Herman has been appointed to the Village of Wellington Planning, Zoning and Adjustment Board (PZAB) for a two year term starting June 2020. The mission of PZAB includes conducting hearings and making recommendations to the Village Council about various land development regulations, acting as the local planning agency, and ruling on variance requests, among the Board’s other duties. Having previously served as Chair, Ron was finishing his term as Vice Chair of the Public Safety Committee. On that… [read post]

Like every other circuit, the Sixth Circuit has produced a lengthy scroll of published cases dealing with predicate offenses under the First Step Act and the Guidelines' career offender provision. The Court's opinion in United States v. Smith continues that trend. Smith pleaded guilty before the district court to distributing a controlled substance in violation  of 21 U.S.C. §§ 841(a)(1) and (b)(1)(C). Due to his prior felony drug trafficking conviction under Ohio law, Smith faced an increased statutory maximum under § 841(b)(1)(C). Finding that Smith was… [read post]

Because of the very nature of physical science and medical science, motorcyclists and motorcycle passengers necessarily are some of the most vulnerable people on the road. While many drivers are vigilant to keep an eye out for all others on the road, too many are prone to overlooking smaller vehicles like motorcycles. When they do, the results can be fatal and tragic. If you or a loved one has been injured in a motorcycle crash in California, you need the right Oakland motorcycle accident attorney on your side to help you as you go through all of the necessary legal steps and processes… [read post]