The U.S. Food and Drug Administration ("FDA") released a draft guidance document in January 2026 titled "FDA Records Access Authority for Cosmetic Products: Guidance for Industry" (the “Draft Guidance”). The Draft Guidance...more
On January 27, 2026, the Department of Health and Human Services, Office of Inspector General (“OIG”) published a Special Advisory Bulletin (the “SAB”) addressing key considerations for pharmaceutical manufacturers' offering...more
Congress Probes Chinese Biotech GLP-1 Product Compliance -
Although the FDA recently implemented additional safeguards related to imported GLP-1 products, the safety of GLP-1 active pharmaceutical ingredient (“API”)...more
On January 6, 2026, the FDA issued a Guidance for Industry and Food and Drug Administration Staff regarding Clinical Decision Support (CDS) software. The January 2026 guidance supersedes the previous, and less detailed,...more
California has enacted two new laws—AB 1415 and SB 351—effective January 1, 2026, that will materially affect private equity ownership and management services structures for physician and dental practices operating in the...more