Drugs

FDAer on Responding to Data Integrity Warning Letters

CDER Office of Compliance manufacturing quality guidance and policy staff director Paula Katz says that three key elements in a drug company’s response to a data integrity Warning Letter are a comprehensive evaluation, risk assessment, and remediation and a management strategy. Speaking at a Parenteral Drug Association Manufacturing Science workshop, Katz said that the agency expects a comprehensive evaluation of a data integrity issue to include (1) a detailed description of strategies and procedures for finding the scope of the problem and determining its root causes; (2) a comprehensive, thorough, and complete evaluation; and (3) a list of records, applications, and other documents that have been or will be examined.

The risk assessment, she said, looks at the potential effect of the data integrity lapse on drug product quality, asking how the deficiencies affect the quality of drugs released for distribution and how batches produced for pending applications were affected.

The management strategy should include details of a global corrective action and preventive action plan, including an analysis of findings, consultant’s recommendations, corrective actions taken, timetable for completion of corrective actions, identification of responsible persons, and procedures for monitoring the plan.

To ensure clear accountability for data integrity in the future, Katz suggested considering implementing an enhanced ethics program and realizing that data integrity problems are not always intentional but sometimes result from poorly controlled systems.

The goal of successful remediation, according to Katz, is for the company and regulators to be able to reconstruct the manufacturing process through records with no data falsification, omission, hiding, or substitution.

She urged companies to voluntarily report data integrity issues to FDA, noting that the agency is much more willing to work with firms that voluntarily disclose and commit to fixing and preventing problems. Companies that uncover a data issue, she said, should determine the scope, severity, and risks; disclose these findings to FDA; and commit to voluntary remediation.

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