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Risk Management › Third-Party › Manufacturers

Foley & Lardner LLP

Episode 36: Let’s Talk Compliance: The Risks and Pitfalls of Health Care Supply Chain Compliance

Foley & Lardner LLP on

In this episode, Monica Chmielewski, vice chair of Foley’s Health Care Practice Group and Shannon Sumner, Chief Compliance Officer and Nashville’s Office Managing Principal of PYA explore how supply chain compliance is...more

Alston & Bird

Addressing Data Integrity Challenges in Medical Device Submissions

Alston & Bird on

The Food and Drug Administration’s (FDA) recent rejection of all study data from Mid-Link Testing highlights the importance of using reliable, valid data for medical device premarket submissions. Our FDA/Food, Drug & Device...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Contradicts Benzene Class Actions, Highlighting Risks of Third-Party Lab Testing

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In March 2024, Valisure, an independent quality advocate, filed a citizen petition claiming to have detected elevated levels of benzene in benzoyl peroxide acne treatment products. Valisure’s petition included testing results...more

Foley & Lardner LLP

Best Practices for Customers Structuring Directed-Buy Arrangements

Foley & Lardner LLP on

This article explores the following topics: (1) What is a directed-buy arrangement? (2) What significant issues exist for a customer in a directed-buy arrangement? and (3) What are the best practices for a customer entering...more

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