Drugs

Hygienic Labs Didn’t Respond to FDA Data Requests

FDA says Hygienic Labs in Denver, CO, a manufacturer of over-the-counter (OTC) drug products, has not responded to several agency requests for records and other information. In a just-released 9/19 Warning Letter, the agency says it is unlawful to refuse to permit access to or copying of any record as required by law.

“Because your OTC drug firm failed to respond to the … records request and associated communications attempts,” the letter says, “we have no indication of quality assurance for drugs registered as manufactured at your facility. Respond to this letter within 48 hours to confirm or update your registration and/or drug listing status and indicate whether you will respond to the request for records and other information.”

FDA says that if Hygienic Labs is no longer manufacturing drugs, it should delist all the drugs previously listed with FDA, using the last expiration date as the marketing end date of the product, and deregister its facility accordingly.

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