Drugs

Establishing Pharmacologic Class MAPP

CDER has issued a Manual of Policies and Procedures (MAPP) outlining the process CDER review staff follows when (1) selecting or creating an established pharmacologic class text phrase that will be associated with an approved indication and included under the Indications and Usage section of labeling; and (2) assigning clinically meaningful and scientifically valid pharmacologic concepts to each active moiety for use in indexing the labeling. The document says the process involves Office of New Drug (OND) pharmacology/toxicology reviewers. The OND associate director for pharmacology and toxicology or other designated staff, other CDER review staff as appropriate, and the Office of the Commissioner/Office of the Chief Scientist health and regulatory data standards staff.

The MAPP defines a pharmacologic class as a group of active moieties that share scientifically documented properties. An established pharmacologic class is a pharmacologic class associated with an approved indication of an active moiety that FDA has determined to be scientifically valid and clinically meaningful according to specific definitions.

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