Drugs

‘Controlled Evidence Ecosystem’ Needed: Expert Column

A review of FDA complete response letters issued between 2018 and 2025 using the keyword “validation” indicates that in about 2% of the letters, the agency raised concerns about audit trails, system validation, spreadsheet controls, data lineage, and incomplete source data traceability. Writing in a BioProcess International column, clinical research and quality professional Sidharth Amanthanarayan says that while those issues may seem minor and limited to a small group within a given company, “they can have a significant impact on a product’s timeline to approval.”

He says that while sponsors might have used various systems to track their data, the information presented to FDA inspectors could not be trusted or accepted because there was limited visibility into the audit trail or the systems’ validation histories.

According to Amanthanarayan, the solution is not to create more documents but to create a controlled evidence ecosystem in which data origin, movement, transformation, review, and approval are visible and defensible. “In that environment,” he says, “audit trails, validation packages, requirements traceability, defect management, migration controls, and secure data traceability are not administrative extras but are the evidence foundation that allows regulators to trust the conclusions built on the data.”

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