Drugs

FDA Denies Food and Supplement Inspection Petition

FDA has denied a 10/17/13 petition from the American Herbal Products Association asking that it (1) formally rescind an agency policy prohibiting investigators from quoting or citing cGMP (current good manufacturing practice) regulations upon which they base inspection findings reported in FDA-483 issued to conventional food and dietary supplement facilities; and (2) revise the Inspection Operations Manual to require that 483s issued to conventional food and dietary supplement facilities reference each cGMP to which the investigator’s listed observations relate.

The denial letter says that the agency has no such policy and cannot rescind a policy that it does not have. “While investigators are limited to recording their factual observations on FDA-483s,” it says, “they are encouraged to relate each listed condition to the applicable sections of law and regulations administered by FDA in their discussions with firm management.”

FDA also declined to revise the inspection observations manual because, it said, the current practice furthers agency interests and promotes understanding, compliance, and transparency.

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