As outlined in our previous post, the Department of Health and Human Services (HHS) has issued a significant Request for Information (RFI) seeking broad public comment on how the agency can accelerate the adoption and use of...more
The U.S. Food and Drug Administration ("FDA") released a draft guidance document in January 2026 titled "FDA Records Access Authority for Cosmetic Products: Guidance for Industry" (the “Draft Guidance”). The Draft Guidance...more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