Biologics

Amnio Technology Illegally Marketing Amniotic Products: FDA

An 8/15-/29/2022 FDA inspection at Amnio Technology in Phoenix, AZ, documented that the firm manufactures an amniotic membrane and fluid product and an amniotic fluid-derived product that have been distributed to third-party distributors, hospitals, and medical clinics in the U.S. A 10/1 Warning Letter says the products are intended for injection and purported to be sterile.

The letter says the products are legally regulated as drugs and biologics and Amnio does not have an approved application for them in effect. It also lists these significant current good manufacturing practice (CGMP) regulation deviations applicable to the firm’s products:

failure to establish written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess;
failure to establish and follow a written testing program designed to assess the stability characteristics of drug products and to use the results of such stability testing to determine appropriate storage conditions and expiration dates; and
failure to follow written procedures describing the handling of all written and oral communications about a drug product.

FDA says the firm’s responses to the form FDA-483 inspection observations were inadequate. Amnio was told to respond with a list of specific steps it has taken to address any violations and prevent their recurrence, with documentation necessary to show that the matters have been addressed and a schedule for completing the corrections.

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