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Food and Drug Administration (FDA) › Data Integrity › Manufacturers

Knobbe Martens

FDA Accuses Third Party Testing Labs of Falsifying Data

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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

Axinn, Veltrop & Harkrider LLP

Doctor Califf Goes to India

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Given its growing role as the “pharmacy to the world,” FDA Commissioner Robert Califf, M.D., recently took a trip to India and offered some of his (and FDA's) views upon his return. During his visit, Commissioner Califf met...more

Ankura

Pharma Companies Can Ensure Data Integrity With User Access Management (UAM)

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Life sciences industry has regulatory compliance at the center of all its operations, so maintaining the integrity of data has always been a pressing need for this industry globally. Regulators such as the United States Food...more

Ankura

How Pharmaceutical Companies Can Manage Data-Integrity Challenges

Ankura on

Human health is a fundamental need of the society. The pharmaceutical industry has played a pivotal role in providing mankind with drugs for preventive and curative care. COVID-19 has further underscored the immense...more

Alston & Bird

New Guidance Refines FDA’s Thinking on Data Integrity

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Our Food, Drug & Device/FDA Group breaks down the new Food and Drug Administration guidance on data integrity for current good manufacturing practices (CGMPs) and what it means for the drug industry....more

Holland & Knight LLP

FDA Commissioner Speaks Out on Compliance and Enforcement

Holland & Knight LLP on

On Dec. 12, 2018, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced tougher compliance and enforcement policies for drug manufacturers, dietary supplement manufacturers, stem cell clinics and...more

Hogan Lovells

FDA Finalizes Data Integrity Guidance, With Some Noteworthy Changes

Hogan Lovells on

Earlier yesterday, FDA published the final guidance “Data Integrity and Compliance With Drug CGMP: Questions and Answers,” which updates April 2016 draft guidance that covers the design, operation, and monitoring of systems...more

Mintz - Health Care Viewpoints

FDA 2017 Year in Review: Therapeutic Products, Part 2

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Yesterday we started off our year-end series of blog posts with the first part of a review of FDA’s actions for 2017 in the therapeutic products space. Part 1 recapped Commissioner Gottlieb’s initiative to tackle drug...more

King & Spalding

FDA Issues Draft Data Integrity Guidance For Current Good Manufacturing Practices

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On April 14, 2016, the U.S. Food and Drug Administration (“FDA”) issued draft guidance titled “Data Integrity and Compliance with CGMP Guidance for Industry” (the “Draft Guidance”). Noting that the FDA has increasingly...more

Morgan Lewis

Follow the Data: FDA Addresses cGMPs for Data Integrity Issues in Draft Guidance

Morgan Lewis on

The draft guidance provides insight into FDA’s expectations regarding data controls and compliance for pharmaceutical companies. In recent years, issues involving the integrity of and controls around manufacturing data...more

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