Medical Device Legal News with Sam Bernstein: Episode 18
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 169: Shirley Paddock, Senior VP of Clinical Development, Syneos Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 168: Christine Harhaj, Senior Director of Advocacy & Strategic Alliances, PhRMA
Podcast: Unpacking FDA's Final Clinical Decision Support Guidance - Diagnosing Health Care
Podcast: Post-Dobbs - Considerations for Clinical Trials and Research - Diagnosing Health Care
Product Launching in the Era of COVID-19 - Diagnosing Health Care Podcast
JONES DAY PRESENTS® Digital Health and Clinical Research: Understanding Regulatory Regimes
JONES DAY PRESENTS® The Impact of Digital Health on Research and Clinical Trials
Nota Bene Episode 75: Clinical Trial Disclosures on the World Map with TrialScope Chief Strategy Officer Thomas Wicks
Podcast: Non-binding Guidance: SEC Disclosure Issues for Life Sciences Companies
Life Sciences Quarterly (Q3 2019): SEC Enforcement and Class Actions Regarding FDA Communications
Podcast: Non-binding Guidance: Real-World Evidence in Drug Development and FDA Submissions
Passage of Federal Right-to-Try law poses risks and opportunities for patients and the biopharmaceutical industry
Life Sciences Quarterly (Q4 2017): The Use of Social Media and Mobile Applications
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
In a recent Advisory Opinion No. 23-11 (Advisory Opinion), the Office of Inspector General (OIG) opined that it will not impose administrative sanctions against a clinical trial sponsor covering up to $2,000 of a clinical...more
Hear directly from the enforcement community - Want to gain insight into properly monitoring, detecting, investigating, and managing violations? Join us at HCCA’s Annual Healthcare Enforcement Compliance Conference to...more
On April 7, the Centers for Medicare & Medicaid Services (CMS) released its highly anticipated final National Coverage Determination (NCD) for Aduhelm and other similar therapies in the pipeline for Alzheimer’s disease. The...more
Hear about the latest in research compliance - Do you want to learn… - How to prepare for upcoming changes in Medicaid? - Ways to build and maintain a better research compliance work plan for your program? - How...more
Right before the new year, we told you about some of the Medicaid-related provisions of the COVID relief package that was recently signed into law by President Trump. One provision of that law that we thought merited a...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more
The U.S. Department of Health and Human Services, Office of the Inspector General (OIG), issued a favorable advisory opinion, No. 17-02, regarding a proposed arrangement under which the cost-sharing amounts owed by...more
The Agency shows no signs of slowing regulatory activity. Although the US Food and Drug Administration’s (FDA’s or the Agency’s) Center for Devices and Radiological Health (CDRH) has been very active throughout 2016, it...more
This Week: Congress Avoids a Government Shutdown... House and Senate Approves Measure to Expand the Affordable Care (ACA) Act Small Group Market to 100 Employees...Affordable Care Act (ACA) Health Insurers to Receive Only...more
On September 25, 2015, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule entitled “Medicare Program: Medicare Clinical Diagnostic Laboratory Tests Payment System”. This proposed rule would...more
Latest Healthcare False Claims Act Roundup and Top 3 Best Practices to Reduce Exposure - As the legal landscape in healthcare becomes increasingly complex, healthcare companies that receive federal program funds face...more
CMS Announces Round 1 2017 DMEPOS Competitive Bidding System – On April 21, 2015, CMS announced plans for a new bidding process for the supplier contracts awarded in the Round 1 Recompete of the DMEPOS Competitive Bidding...more