Can Food Really Be Medicine? Transforming Health Care One Bite at a Time – Diagnosing Health Care Video Podcast
Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
AGG Talks: Cross-Border Business Podcast - Episode 22: What Global Companies Need to Know About Navigating FDA Regulations and U.S. Market Entry
AI and Pharmacovigilance Under the FDA's New Emerging Drug Safety Technology Program – The Good Bot Podcast
GLP-1 Drugs and Cultivated Meat: What’s the Impact on the Food and Agriculture Industry?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 202: Life Sciences Startups and Industry Developments with Gil Price, Life Sciences Leader
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Video: Food for Thought and Thoughts on Food: Innovating USDA Science with Sanah Baig, Deputy Under Secretary for Research, Education, and Economics
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Litigating Nutrition: Class Action Battles Over Dietary Supplements – Speaking of Litigation Video Podcast
Changes in FDA, Cannabis Policies and AI Developments
Ad Law Tool Kit Show – Episode 2 – Marketing FDA-Regulated Products
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
A Look Into the FDA and USDA Regulatory Regimes
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Recent activity among lawmakers and federal agencies signal that the government may be poised to undertake meaningful legislative and administrative efforts to harness the potential of digital health innovation and to expand...more
Healthcare in the United States is undergoing significant changes, particularly in the areas of reimbursement and coverage of telehealth, substance use disorders (SUDs), and mental health services. The proposed 2025 Physician...more
The Centers for Medicare & Medicaid Services (CMS) have released significant updates affecting Medicare payments for 2025. The changes, outlined in two final rules, will impact both physicians and hospitals, eliciting strong...more
The Centers for Medicare & Medicaid Services (CMS) released a Final Notice for Transitional Coverage for Emerging Technologies (TCET), effective August 12, 2024, to provide “transparent, predictable, and expedited national...more
Obtaining Medicare coverage and reimbursement for medical devices is notoriously more difficult than for drugs or biologics, and any progress on expanding coverage pathways has been agonizingly slow for industry stakeholders....more
Pharma’s favorite summer pastime is back again: reviewing the Centers for Medicare & Medicaid Services (CMS) release of the 2025 proposed Hospital Outpatient Prospective Payment System (HOPPS) and Physician Fee Schedule (PFS)...more
In recent years, the Centers for Medicare & Medicaid Services (CMS) has expanded payment for remote monitoring services in an effort to pay for non-face-to-face services that improve care coordination for Medicare...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for July 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act...more
Sophisticated clinical software systems employed in specific health care services have graduated from being interfaces, operating systems, and subordinate tools that support physical medical devices and have matured to the...more
+Dx Forum 2023 is the premier gathering for the laboratory diagnostics community. Join us for insightful discussion about the latest regulatory and reimbursement developments....more
As the nomination of Dr. Robert Califf to head the federal Food and Drug Administration advances, he and the agency already are confronting a major regulatory crisis over Aduhelm, a prescription drug targeted for Alzheimer’s...more
SCOTUS Halts OSHA’s Vax-or-Test ETS (but Greenlights CMS Rule). On January 13, 2022, the Supreme Court of the United States stayed the Occupational Safety and Health Administration’s (OSHA) COVID-19 vaccination-or-testing...more
On November 19, 2021, OIG issued Advisory Opinion No. 21-17 in which it responded to a request for an advisory opinion regarding a proposed subsidization of certain Medicare cost-sharing obligations in the context of a...more
In Washington: State public health officials are urging Congress to provide at least $8.4 billion in emergency funding for distributing a coronavirus vaccine, warning that they lack enough money to carry out the immense...more
Personalized medicine can be described as the science of targeted therapies. Advances in diagnostic and molecular medicine have made it possible to more precisely identify alternative treatment options for patients based on...more
Guest Post By: Perry Dimas, Senior Vice President and General Manager for Premier Source, part of AmerisourceBergen The 2015 Business of Personalized Medicine Summit was an inspiring day with talented professionals. One...more
In the wake of a new Medicare reimbursement framework, FDA plans stricter regulation of some in vitro diagnostic devices. On July 31, 2014, the U.S. Food and Drug Administration (FDA; Agency) announced its intent to...more