Drugs

CDER Expectations for CGMP, Data Integrity

Two CDER staffers from the Office of Compliance and Office of Pharmaceutical Quality discussed the Center’s expectations for data integrity and compliance with CGMP at the Society of Quality Assurance annual meeting. They said that 2016 enforcement actions, not including compounding-related action, involved 47 import alerts, 4 Untitled Letters, 54 Warning Letters, 27 instances involving regulatory discretion, and 27 regulatory meetings.

Much of the discussion involved data integrity, which was defined as a requirement that data are complete, consistent, and accurate. The acronym ALCOA was shared — attributable, legible, contemporaneous, original/true copy, and accurate.

Current Good Manufacturing Practices (CGMP) are minimum requirements, the speakers said, and data integrity underpins CGMP. They noted that requirement for record retention and review do not differ by data format; paper-based and electronic data record-keeping systems are thus subject to the same requirements.

Data integrity concepts covered in the presentation with definitions and case studies were metadata, audit trail, static versus dynamic records, backup data, and system validation.

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