Infant botulism is normally sporadic; most cases involve one infant, one household, and no single identified commercial source. Bacterial spores are widely present in soil and dust around the country and therefore may cause sporadic, random infections. A
The 2026 cyclosporiasis season closed on August 31. Between July 14 and August 13, thirteen letters went from members of the House and Senate to the Secretary of Health and Human Services, to the acting heads of FDA and
CDC declared this outbreak over on August 26, 2026, and FDA closed its investigation the same day. Fifteen people in four states — Illinois, Maryland, New York and Virginia — were infected with the outbreak strain of Listeria monocytogenes. Fourteen were
San Diego County published a new release at 4:37 this afternoon, and it closes the hole that has sat in the middle of this outbreak for six weeks. The U.S. Food and Drug Administration collected samples inside the Happy Hens
On August 11, 2026, the Health Resources and Services Administration (“HRSA”) released its Health Center Program Scope of Project Policy Manual (“Scope Manual”), providing comprehensive guidance on what constitutes a health center’s approved scope of project under Section 330
Federal enforcement of fraud involving taxpayer-funded programs, like Medicare, is intensifying and businesses that work with the US government should be paying close attention. The US Department of Justice’s latest guidance is designed to accelerate qui tam investigations, increase the
By Kevin E. Noonan –Written description jurisprudence has been one of the areas of statutory explication of Section 112(a) (along with enablement) primarily under the purview of the Federal Circuit (until the Supreme Court’s Amgen v. Sanofi decision on enablement;
Jenkins v National Disability Insurance Agency [2026] FCA 1307 (Link to AUSTLII).
With thanks to Anna Sundararajan for drawing attention to this decision where the Federal Court was called upon to consider the powers of the NDIA to recover
