Drugs

Live Biotherapeutic Product Guidance Out

FDA has issued a guidance, Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing and Control Information, to assist IND sponsors with submissions for early clinical trials with live biotherapeutic products (LBP), including those lawfully marketed in the U.S. as foods, such as conventional foods and dietary supplements. The document focuses on the chemistry, manufacturing, and control (CMC) information that should be submitted in an IND for a LBP. It applies to all INDs of LBPs, whether clinical trials are conducted commercially, in an academic setting, or otherwise under applicable regulations. It does not, however, apply to LBPs intended as gene therapy, vectors, to oncolytic bacteria, or to oncolytic viruses.

This guidance updates one issued in 2/2012 by including a new section to address when the label on commercially available products would be considered adequate to satisfy the purpose of the CMC information requirements. It also removes the General Safety Test as an example of a test method, and updates certain footnotes, references, and addresses.

The document includes Introduction and Background, Administrative and Regulatory Procedures, CMC Information, Non-Clinical Information, Clinical Information, and References.

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