Drugs

Multiple Violations at BioPure Healing Products

A 10/15-11/8/19 FDA inspection at BHP Holdings, doing business as BioPure Healing Products, Woodinville, WA, found serious violations of the Federal Food, Drug, and Cosmetic Act and applicable regulations for dietary supplements. A 6/17 Warning Letter says the company failed to review all product complaints to determine whether the complaint involves a possible failure of a dietary supplement to meet any of its specifications or any other regulatory requirement that, if not met, may result in a risk of illness or injury. The letter also lists several reasons why FDA considers some of the firm’s products to be misbranded.

According to FDA, the company’s 1/17 response provided revised procedures for product complaints and adverse event reporting, as well as a record of the training provided on the procedures. The agency says that based on the documentation provided in the firm’s 3/17 response, the agency has ongoing concerns with the firm’s review and investigation of product complaints it receives.

BioPure was told to respond with a list of specific steps taken to correct the violations and prevent their recurrence, with the documentation for each step and a timetable for completion.

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