Drugs

FDA Warns on Burkholderia Cepacia Contamination

FDA is warning drug manufacturers of non-sterile, water-based drug products that there have been the subject of recent product recalls due to Burkholderia cepacia complex (BCC) contamination. “BCC and other water-borne opportunistic pathogens are among the contaminants that can be found in pharmaceutical water systems,” an agency safety alert says. “People exposed to BCC are at an increased risk for illness or infection, especially patients with compromised immune systems.”

Specifically, FDA is reminding drug manufacturers to:

Establish procedures designed to prevent objectionable microorganism contamination of non-sterile drug products (e.g., procedures to assure adequate quality of incoming materials, sanitary design, equipment maintenance and cleaning, production and storage time limitations, and environmental monitoring).
Use scientifically sound and appropriate acceptance criteria and test procedures to assure that drug product components and finished drug products conform to quality standards.

Provide appropriate drug product specifications (tests, methods, and acceptance criteria) in applications submitted to the FDA. In some cases, additional laboratory tests may be needed to determine whether products are suitable for release.

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