Life Sciences Legal Update, published by Reed Smith LLP, focuses on legal developments affecting multinational and global life sciences companies. The blog covers topics such as regulatory guidance from agencies like the FDA, product recalls, patent law issues including AI inventorship, and compliance with evolving healthcare and pharmaceutical regulations. It also addresses litigation trends, industry-specific legislative changes, and risk management strategies relevant to drug and medical device manufacturers. The blog serves as a resource for legal professionals and industry stakeholders seeking updates on the intersection of law and life sciences business operations.
On Thursday, January 23, 2020 at 12:00 PM ET, Reed Smith will be hosting “Digital Health 101”, a CLE webinar covering:
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On December 23, 2019, the U.S. Food and Drug Administration (FDA) published in the Federal Register a set of proposed rules covering the requirements and procedures for importing under Section 804 of the federal Food, Drug, and Cosmetic Act (FDCA)…
On Wednesday, November 20, a three-judge panel of the U.S. Court of Appeals for the Eleventh Circuit heard oral argument in the closely watched False Claims Act (FCA) case of United States ex rel. Ruckh v. Salus Rehabilitation, Inc. The…
As 2019 comes to an end, the United States Food & Drug Administration’s (“FDA” or the “Agency”) Center for Veterinary Medicine has published a new draft Guidance for Industry #256, “Compounding Animal Drugs from Bulk Drug Substances” (the “Draft Guidance”). …
The U.S. Department of Health and Human Services Office for Civil Rights’ (OCR) recent imposition of a civil monetary penalty (CMP) against a Health Insurance Portability and Accountability Act of 1996 (HIPAA) covered entity demonstrates the need to ensure that…
Please join us for our 6th Annual Washington Health Care Conference, a program discussing the latest hot topics and anticipated trends impacting health care and life sciences organizations. This year’s program will be held on December 4, 2019 at…
On October 13, 2019, California Governor Gavin Newsom signed into law Assembly Bill 744 (AB 744), marking the latest of many state legislative efforts to modernize health care by ensuring that telehealth services are paid and covered, similar to their…
Please join us for the next edition of Reed Smith’s FDA webinar series, “CBD: What now?”, on Wednesday, October 30, 2019 at 12:00 PM ET.
Cori Goldberg, Marc Hauser, and Adam Brownrout will offer a summary of current federal (FDA,…
The Drug Enforcement Administration (“DEA” or the “Administration”) recently published a notice in the Federal Register (volume 84, number 189, pages 51368–51377) that the Administration is amending its regulations and issuing a final rule to implement not only a new…
Last Thursday, the California Attorney General, Xavier Becerra, released the long-awaited text of the proposed California Consumer Privacy Act (CCPA) regulations. Once finalized, these 24 pages of regulations will govern compliance with the CCPA. While the draft regulations provide insight…
