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Food and Drug Administration (FDA) › Data Integrity › Third-Party

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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