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Articles: 1-10 of 230
USA - June 1 2022 Most companies want to avoid FDA Warning Letters. To help medical device companies identify violations that might lead to a warning letter, this post…
USA - April 21 2022 On April 14, 2022, the Centers for Medicare & Medicaid Services (CMS) issued new guidance on the Independent Dispute Resolution (IDR) process…
USA - April 8 2022 On April 7, 2022, the Centers for Medicare and Medicaid Services (CMS) issued guidance terminating numerous blanket waivers applicable to skilled…
USA - April 8 2022 The Department of Health and Human Services (HHS) Office for Civil Rights (OCR) recently submitted two reports to Congress setting forth the HIPAA…
USA - March 1 2022 I recommend against relying on any data I provide in today’s post. I hope the data are at least somewhat accurate. But they are not nearly as…
USA - February 28 2022 On February 23, 2022, in the case captioned Texas Med. Ass’n v. U.S. Dep’t of Health & Human Servs., No. 6:21-cv-00425-JDK (E.D. Tex.), the U.S…
European Union, USA - February 28 2022 Recent decisions from the European Union (EU) have placed renewed focus on the use of common cookies used on ecommerce and other websites used by…
USA - February 15 2022 During a National Stakeholder Call on January 18, 2022, Ellen Montz—Deputy Administrator and Director of the Center for Consumer Information and…
USA - February 11 2022 On February 4, 2022, the Centers for Medicare and Medicaid Services (CMS) issued important updated guidance in a memo (QSO-21-08-NLTC) regarding how…
USA - February 1 2022 The United States Food and Drug Administration (FDA) for many years has been trying to increase the participation of minorities in clinical trials to…