2/10/2026 10:51:34 PM FDA Cosmetics Compliance: Understanding FDA Records Access Under MoCRA By Caitlin Kierum Vinal Patel The U.S. Food and Drug Administration ("FDA") released a draft guidance document in January 2026 titled "FDA Records Access Authority for...
2/5/2026 9:17:35 PM Pharmaceutical Direct to Consumer Programs: OIG's Low-Risk Roadmap for Drug Discounts & Congressional Concerns on TrumpRx Compliance By Vinal Patel Caitlin Kierum On January 27, 2026, the Department of Health and Human Services, Office of Inspector General (“OIG”) published a Special Advisory...
2/3/2026 10:55:45 PM Congress Probes Chinese Biotech GLP-1 Product Compliance By Vinal Patel Caitlin Kierum Congress Probes Chinese Biotech GLP-1 Product Compliance Although the FDA recently implemented additional safeguards related to imported...
2/2/2026 9:29:50 PM FDA Clinical Decision Support Software Guidance Refresh : Clearer Rules, Broader Innovation By Anthony Del Rio Vinal Patel Caitlin Kierum On January 6, 2026, the FDA issued a Guidance for Industry and Food and Drug Administration Staff regarding Clinical Decision Support...
4/7/2021 10:47:12 AM Keeping Up With COVID-19 Vaccines and Testing Strategies By Katten As of April 6, 2021, there are 355 different tests available. Each of these tests have their own regulatory requirements and their own...