CSU Law Library Blog

The U.S. Food & Drug Administration (FDA) recently released an Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula Market.  The Food and Drug Omnibus Reform Act of 2022 directed the FDA to work with the Department of Agriculture and other relevant government agencies to develop “a national strategy on infant formula to increase the resiliency of the infant formula supply chain, protect against future contamination, and other potential causes of supply disruptions and shortages, and ensure parents and caregivers have access to infant formula and information they need.” [See Pub. L. No. 117-328, Title III, Subtitle D, § 3401(j), 12/29/2022.]  This legislation responded to the extreme infant formula shortage in early 2022, when supply chains were stressed by the COVID-19 pandemic and exacerbated by Abbott Nutrition’s voluntary recall of infant formula products.  In 2024, with input from the National Academies of Sciences, Engineering, and Medicine, the FDA will issue a long-term national strategy “to improve preparedness against infant formula shortages by outlining methods to improve information-sharing, recommending measures for protecting the integrity of the infant formula supply chain, and preventing contamination.”  For more information, see the FDA Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula Market page.

The U.S. Food & Drug Administration (FDA) recently announced draft guidance for industry on the Development of Local Anesthetic Drug Products with Prolonged Duration of Effect.  Guidance recommendations “are intended to assist developers in generating the data necessary to support different indications and labeling claims for these drugs.”  Local anesthetic drug products have been used for pain relief following surgical procedures, but many are only effective for several hours.  “This guidance focuses on local anesthetic drug products that prolong the duration to a period of days,” and “is part of FDA’s efforts to reduce or eliminate the use of opioid analgesic drug products.”  To ensure agency consideration, comments should be submitted by June 14, 2023.  For more information, see the FDA draft guidance. [88 Fed. Reg. 16,265 (March 16, 2023)]

The Legal History and Rare Books Special Interest Section (LHRB) of the American Association of Law Libraries (AALL), in cooperation with Gale, a Cengage Company, is conducting its annual Morris L. Cohen Student Essay Competition.  Full- and part-time students currently enrolled in accredited graduate programs in law, history, library science, or related fields are eligible to enter.  Essays may be on any topic related to legal history, rare law books, or legal archives.  Criteria on which papers will be judged include originality of topic or approach, quality and depth of research and analysis, clarity of presentation, and contribution to the field.  The winner will receive a $1,000 prize from Gale.  The authors of the winning and runner-up essays will have the opportunity to publish their essays  in LHRB’s online annual scholarly journal Unbound:  A Review of Legal History and Rare Books.  The Competition electronic submission deadline is 11:59pm EDT, Monday, 15 May 2023.

Full Competition details and Application Form are available at the LHRB SIS Morris L. Cohen Student Essay Competition web page.  Questions can be sent to Linda K. Tesar (lktesar@wm.edu), Head of Technical Services & Special Collections, William & Mary Law School.  The Competition is named in honor of Morris L. Cohen, late Professor Emeritus of Law at Yale Law School and recognized as “one of the towering figures of late 20th century law libraries.”  His scholarly work  focused on legal research, rare law books, and historical bibliography.

The U.S. Food & Drug Administration recently announced an emergency use authorization (EUA) for the Lucira COVID-19 & Flu Home Test – the “first over-the-counter (OTC) at-home diagnostic test that can differentiate and detect influenza A and B, commonly known as flu, and SARS-CoV-2, the virus that causes COVID-19.”  The Test can be bought without a prescription and is performed “using nasal swab samples self-collected by individuals ages 14 years or older or collected by an adult for individuals 2 years of age or older.”  A sample swab is swirled in a viral, the viral is placed in the test unit, and results are display in 30 minutes.  In individuals with symptoms consistent with a respiratory tract infection, the Test “correctly identified 99.3% of negative and 90.1% of positive Influenza A samples, 100& of negative and 88.3% of positive COVID-19 samples, and 99.9% of negative Influenza B samples.”  The Test’s EUA requires Lucira to continue to collect samples to study its ability to detect Influenza B.  For more information, see the 2/24/2023 FDA EUA letter.

The U.S. Supreme Court this week declined to hear the appeal of a Parma man, Anthony Novak, who sued the city’s police department after being arrested for creating a fake police Facebook page that lampooned the department (2023 WL 2123743).

Novak sued the city after his acquittal, arguing the city violated his First Amendment rights to free speech. The Sixth Circuit sided with Parma, (33 F.4th 296), saying that qualified immunity shielded the city from civil liability.

The Supreme Court’s decision will allow the lower courts’ decisions to stand.