Gardner.law

FDA Issues Draft Guidance on Real-World Evidence Use

WEBby Nathan Downing In December 2023, the U.S. Food and Drug Administration (FDA) issued draft guidance on the use of real-world evidence to support regulatory decision …

Actived: 7 days ago

URL: https://gardner.law/news/fda-new-draft-guidance-for-medical-devices

Highlights from OIG’s New Compliance Program Guidance

WEBMarch 04, 2024. The U.S. Department of Health and Human Services Office of Inspector General (HHS OIG) released an important new compliance resource in November 2023. …

Category: Health Go Health

In the Wake of the Safe Harbor Updates

WEBAt a high-level, the Electronic Health Records Safe Harbor has been updated to protect certain cybersecurity software and services (e.g., electronic health record or "EHR" …

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The Evolving FDA Regulatory Landscape of Artificial Intelligence

WEBMarch 29, 2023. As artificial intelligence technology evolves on a seemingly minute-by-minute basis, the U.S. FDA's regulatory approach continues to evolve in an effort to …

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Amidst Legal Fight, HHS Revises Online Tracking Guidance

WEBOn March 18, 2024, the Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services (HHS) issued revised guidance on the use of tracking technologies by …

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What Manufacturers Need to Know About PFAS

WEBApril 09, 2024. Manufacturers of all types of products have been using per- and polyfluoroalkyl substances (PFAS) for decades. From a manufacturing perspective, …

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Does your compliance program meet the revised AdvaMed Code

WEBThe revised Code provides principles for companies to follow: (1) support only at the request of and under supervision of HCP; (2) role as technical support is …

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FDA Violations and the Park Doctrine Threat

WEBBy Amanda Johnston. Did you know… As a leader at an FDA-regulated company, you could be held criminally liable for misdemeanor FDA violations even if you did not know …

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Experience That Delivers Results

WEBSectors. Gardner Law specializes in FDA-related legal matters, offering expert transactional and litigation counsel across diverse industries. Our overarching mission is to positively …

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Med-Tech Meets High-Tech: Privacy, Cybersecurity and AI in …

WEBPaul Rothermel presented on Med-Tech Meets High-Tech at a recent CLE program that Gardner Law and Fieldfisher hosted in Huntington Beach, California.If you don't have …

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US State Privacy Law Replay 2023

WEBby Paul Rothermel and Theo Thompson 2023 is finally in the books and so are many new privacy laws. Just in case you missed some of the numerous changes, this short article …

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Sunshine, FDA Commissioner, & Gardner News

WEB2020 Regulatory Update from Both Sides of the Pond Last fall we held a c omplimentary 4-part webinar series tailored to MedTech and Pharma companies. Watch presentations …

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Seeking FDA Emergency Use Authorization for a COVID-19 …

WEBSeeking FDA Emergency Use Authorization for a COVID-19 medical device? April 22, 2020

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2020 Regulatory Update from Both Sides of the Pond

WEBRegulatory. Health Care Compliance. Due Diligence for Buyers and Sellers. Attendees include legal, compliance, regulatory, quality, and privacy professionals. CLE credits - …

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AdvaMed Code 2022 Updates: What you need to know.

WEBBy Amanda Johnston, JD, RAC. On March 18, 2022, the Advanced Medical Technology Association ("AdvaMed") announced approval of a revised Code of Ethics …

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New WA Privacy Law ‘Turns The Beat Around’ on Drug and Device …

WEBby Paul Rothermel, J.D., CIPM. The Washington My Health My Data Act ("MHMDA") may not have been written by Earth, Wind, & Fire, but it is certainly poised to make medical …

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Senators Urge FDA: Fix Ad Oversight

WEBOn February 14, 2024, Senators Richard Durbin and Mike Braun sent a letter to the U.S. Food and Drug Administration (FDA) urging it to address what they view as “gaping …

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New Jersey Passes Comprehensive Consumer Privacy Law

WEBHere are some of the key provisions of which business owners and executives should be aware: 1. Applicability. Entities that are subject to New Jersey’s privacy law are those …

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Was it something I said

WEBOctober 04, 2021. By Mark Gardner, MBA, JD. Clients often ask if they can talk about a product before FDA approval. It can be done but important rules must be followed or …

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