Drugs

Multiple Violations in Brunner Hygiene Unapproved New Drugs

An FDA review of records requested from Thomas Brunner GmbH, a Baden-Württemberg, Germany, over-the-counter drug manufacturer, identified significant violations in the firm’s manufacturing of misbranded, unapproved drugs. A 7/24 Warning Letter lists these violations of the Federal Food, Drug, and Cosmetic Act:

failure to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, before release;
failure to establish adequate written procedures for production and process control designed to assure that manufactured drug products have the identity, strength, quality, and purity they purport or are represented to possess, and failure to establish and follow adequate written procedures for cleaning and maintenance of equipment;
failure to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality; and
failure to establish and follow a written testing program designed to assess the stability characteristics of drug products.

The letter also says the firm’s syNeo antiperspirant products are legally considered to be unapproved new drugs that are misbranded because they don’t comply with applicable marketing regulations.

FDA recommends that Brunner retain a qualified consultant to assist it in meeting current good manufacturing practice requirements. It says the company is responsible for investigating and determining the root cause of any violations and implementing corrective and preventive measures to ensure future and sustained compliance so that the stated violations and any others do not occur.

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