Food, Drugs, Healthcare, Life Sciences

Subscribe
Welcome to the Mondaq Food, Drugs, Healthcare, Life Sciences homepage, here you will find thought leadership articles, podcasts, videos and webinars providing insights covering topics such as Food and Drugs Law, Healthcare, Life Sciences, Biotechnology and Nanotechnology.
Article
MSDH Approves Major Updates to State Health Plan and CON Review Manual
Mississippi's State Department of Health has approved significant revisions to its State Health Plan and Certificate of Need Review Manual, introducing new capital expenditure thresholds, expanded exemptions, and updated requirements for imaging services, home health, ESRD facilities, and rural hospital projects. The changes track recent legislation and include a comprehensive reorganization of CON application processing rules that may affect whether healthcare projects require state approval.
United States Healthcare
BS
Butler Snow LLP
Article
Oversight Of Laboratory Developed Tests One Year After ACLA v. FDA: Assessing Legislative Proposals In Context
The regulatory landscape for laboratory-developed tests is undergoing significant transformation following the vacatur of FDA's 2024 LDT Final Rule, creating both uncertainty and opportunity for laboratories, test developers, and diagnostic manufacturers. With attention shifting toward potential CLIA-based oversight administered by CMS and new legislative proposals emerging, stakeholders face a fragmented regulatory environment requiring strategic navigation across multiple federal and state authorities.
United States Healthcare
AP
Arnold & Porter
See more

Webinars

See More

Highlighted Content

Healthcare

Article
New Obstacles For Healthcare: Federal And State National Security Regulations Increasingly Target Health Data
Federal and state regulations are creating a complex, multi-layered framework for protecting American health and genomic data, forcing healthcare organizations to navigate overlapping compliance obligations. Life sciences companies, clinical laboratories, telehealth platforms, and consumer health brands now face the challenge of determining which regulations apply to their operations and how to effectively allocate compliance resources across this evolving landscape.
United States Government
KD
Kelley Drye & Warren LLP
Article
MSDH Approves Major Updates to State Health Plan and CON Review Manual
Mississippi's State Department of Health has approved significant revisions to its State Health Plan and Certificate of Need Review Manual, introducing new capital expenditure thresholds, expanded exemptions, and updated requirements for imaging services, home health, ESRD facilities, and rural hospital projects. The changes track recent legislation and include a comprehensive reorganization of CON application processing rules that may affect whether healthcare projects require state approval.
United States Healthcare
BS
Butler Snow LLP
See more

Food and Drugs Law

See more

Life Sciences, Biotechnology & Nanotechnology

Article
FDA Approves Orca Bio’s TREGZI For Allogeneic Hematopoietic Transplants
Orca Bio's TREGZI has received FDA approval as the first precision-engineered cell therapy for matched donor hematopoietic stem cell transplantation in adults with blood cancers. The therapy combines three types of immune cells to reconstitute the immune system and significantly improve chronic graft-versus-host disease-free survival rates. Clinical trial data showed 78% of patients receiving TREGZI achieved higher GVHD-free survival compared to just 38% with conventional transplant methods.
United States Healthcare
GP
Goodwin Procter LLP
See more

Latest Videos

See more

Upcoming Events