Drugs

CDER Reorganization Clears Congress

CDER director Janet Woodcock says the reorganization aspect of the Center’s new drugs regulatory program modernization has cleared Congress and the next phase of the plan is being implemented. The intent of the modernization is to streamline resources so that doctors and staff can dedicate more time to drug development activities, particularly drugs under the agency’s review for unmet medical needs, she says.

“Modernizing our operations helps us perform our mission effectively in an environment of rapidly evolving science, changing stakeholder expectations, and new statutory authorities and responsibilities,” Woodcock says. “The new structure will strengthen operations in a number of CDER offices and will allow FDA to better meet the evolving needs of new drug review.”

Provisions of the reorganization include increasing the number of review divisions, allowing each to specialize in certain types of drugs, while also increasing the effectiveness and efficiency of review. The Office of Translational Sciences and the Office of Pharmaceutical Quality, which work closely with the Office of New Drugs, are also undergoing a restructuring of clinical offices and divisions as part of the reorganization, Woodcock says. Changes that will begin include:

grouping Office of New Drugs offices by therapeutic area to distribute workload and align to changes in the pharmaceutical landscape;
increasing the number of clinical offices that oversee review divisions from six to eight;
increasing the number of clinical divisions from 19 to 27, plus six divisions of pharmacology/toxicology, creating divisions with clearer and more focused areas of expertise; and
establishing the new Offices of Program, Administrative, and Regulatory Operations, an Office of New Drug Policy, and an Office of Drug Evaluation Sciences.

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