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Third-Party Data Integrity Manufacturers

Knobbe Martens

FDA Accuses Third Party Testing Labs of Falsifying Data

Knobbe Martens on

The Food and Drug Administration (FDA) recently issued General Correspondence Letters to two third-party nonclinical testing laboratories. The FDA cited the laboratories “after discovering data that was falsified or otherwise...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

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