Drugs

FDA Final Data Integrity Guidance Reviewed

The FDA 12/12/18 final guidance on data integrity and compliance with CGMP (current good manufacturing practice) says that management with executive responsibility has the role of creating a quality culture in which employees understand the importance of data integrity and are encouraged to identify and promptly report data integrity issues. Duane Morris attorneys write in an online alert that the absence of management support of a quality culture can lead to breakdown of quality systems and to CGMP noncompliance. To ensure CGMP compliance, they write, FDA recommends that management ask whether:

controls in place to ensure that data is complete;
activities are documented at the time of performance;
activities are attributable to a specific individual;
only authorized individuals can make changes to records;
there is a record of changes to data;
records are reviewed for accuracy, completeness, and compliance with established standards; and
data are maintained securely from data creation through disposition after the record retention period.

“FDA links data integrity to the CGMP data lifecycle,” the alert says, “including creation, modification, processing, maintenance, archival, retrieval, transmission, and disposition of data after the record’s retention period ends. FDA recommends the use of system design and controls to simplify the detection of errors, omissions, and aberrant results.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome