Drugs

Office of Generic Drugs New Reorganization

CDER has announced that a planned Office of Generic Drugs (OGD) reorganization has been approved and will be implemented later this year. The new structure is intended to strengthen OGD’s operations and allow it to meet generic drug review expectations, according to an agency release. Changes include establishing a new Office of Safety and Clinical Evaluation, which comprises the Division of Clinical Review and the Division of Pharmacology Toxicology Review, both being realigned from OGD’s Office of Bioequivalence; and the Division of Clinical Safety and Surveillance that is being realigned from OGD’s immediate Office.

“New divisions will be established in existing OGD offices, including the Division of Bioequivalence Process Management (Office of Bioequivalence), the Division of Therapeutic Performance II (Office of Research and Standards), and the Division of Orange Book Publication and Regulatory Assessment (Office of Generic Drug Policy),” the release says. “Lastly, the Division of Quality Management Systems will move from the Office of Regulatory Operations to become the Quality Management Systems Staff within OGD’s Immediate Office. Through the reorganization, OGD intends to continue its focus on ensuring a more efficient review process and create a stronger alignment of administrative, regulatory project management, program operations, policy, and drug development tool services.”

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