Drugs

CDER, ORA Pen Operational Agreement for Inspections

CDER and ORA have announced a “concept of operations” agreement to integrate facility evaluations and inspections for human drugs. The agreement, Integration of FDA Facility Evaluation and Inspection Program for Human Drugs: A Concept of Operations, outlines responsibilities and the workflow for pre-approval, post-approval, surveillance, and for-cause Inspections at domestic and international facilities. The agreement will allow the two organizations to “more effectively manage the growing complexity of the pharmaceutical landscape,” the agency says, and to meet new challenges by:

Ensuring consistency, efficiency, and transparency in facility evaluations, inspections, and regulatory decision-making for marketing applications across FDA;
Advancing strategic alignment across ORA and CDER functional units by creating clear roles and responsibilities;
Improving FDA’s operational capacity by enhancing collaboration between various CDER and ORA offices;
Enhancing the quality and increasing access to facility and regulatory decisional information across FDA; and
Meeting user fee commitments and improving the timelines for regulatory, advisory, and enforcement actions to protect public health and promote drug quality, safety, and effectiveness.

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

Read more

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