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Medical Devices › Best Practices › Compliance

Gardner Law

Change Control Pitfalls: Legal & Regulatory Risks in FDA-Regulated Industries

Gardner Law on

Obtaining FDA clearance or approval is just the beginning of a company’s regulatory journey. As FDA-regulated products evolve, changes to software, labeling, manufacturing processes, and design are a natural part of the...more

Hendershot Cowart P.C.

Qlarant, Novitas Audits Escalate as Medicare Skin Substitutes Spending Hits $1.6 Billion, CMS Seeks Evidence of Clinical...

Hendershot Cowart P.C. on

The wound care industry faces unprecedented scrutiny as Medicare Part B expenditures for skin substitutes exceeded $1.6 billion in the fourth quarter of 2023 alone. The spending surge has triggered a wave of skin substitute...more

Mintz - Health Care Viewpoints

Health Law Diagnosed – Best Practices for Communicating with the FDA

Mintz - Health Care Viewpoints on

In the latest episode of Health Law Diagnosed , Of Counsel Bridgette Keller hosts a discussion of best practices for interacting and communicating with the FDA....more

Mintz

[Podcast] Health Law Diagnosed – Best Practices for Communicating with the FDA

Mintz on

In the latest episode of Health Law Diagnosed , Of Counsel Bridgette Keller hosts a discussion of best practices for interacting and communicating with the FDA. Hear from Joanne Hawana and Ben Zegarelli, FDA specialists...more

Foley & Lardner LLP

Artificial Intelligence in Health Care: Key Considerations for Oncology

Foley & Lardner LLP on

Artificial intelligence (AI) has the power to revolutionize health care. In oncology, there are now opportunities to apply AI to support diagnostics, predictive analytics, and administrative functions. This hot topic was...more

American Conference Institute (ACI)

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - May 9th - 10th, New York, NY

American Conference Institute (ACI) on

Hosted by the American Conference Institute, the 19th Annual FCPA & Anti-Corruption Conference for the Life Sciences Industry returns for another exciting year with carefully researched programming based on critical findings...more

Health Care Compliance Association (HCCA)

Transparency and the Open Payments Program

Health Care Compliance Association (HCCA) on

To quote CMS, “The Open Payments program is a national disclosure program that promotes a more transparent and accountable health care system. Open Payments houses a publicly accessible database of payments that reporting...more

American Conference Institute (ACI)

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - July 21st - 22nd, Boston, MA

American Conference Institute (ACI) on

ACI is excited to welcome you back in-person to the 14th Advanced Forum on FCPA & Anti-Corruption for the Life Sciences Industry, taking place on July 21–22, 2022 in Boston! Legal and compliance professionals from...more

Health Care Compliance Association (HCCA)

[Event] Research Compliance Conference - June 8th - 10th, Anaheim, CA

Health Care Compliance Association (HCCA) on

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

Health Care Compliance Association (HCCA)

[Virtual Event] 2021 Research Compliance Conference - June 14th - 16th, 9:00 am - 5:00 pm CDT

Health Care Compliance Association (HCCA) on

Attend HCCA’s annual Research Compliance Conference to receive the latest insights and guidance on emerging research compliance risks and solutions. This virtual event, held June 14 – 16, will be live and interactive. Learn...more

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