Drugs

Combo Compliance Manual Includes Streamlined Approach

Six Hogan Lovells attorneys say the 6/4 FDA update to the Compliance Program Guidance Manual (CPGM) includes a program for inspecting CDER-led and CDRH-led combination products. In an online post, the attorneys write that the updated manual says it “focuses on inspections of combination product manufacturers of CDER or CDRH-led single-entity and co-packaged finished combination products that include both drug and device or biological product and device constituent parts” and is intended to clarify or explain the application of current good manufacturing practice (cGMP) requirements to combination products laid out in a 1/2017 final guidance, including the application of the “streamlined approach” to cGMP compliance outlined in the final guidance.

Because most combination product manufacturers have adopted a streamlined approach to demonstrating cGMP compliance, the attorneys write, the manual focuses on providing instructions to FDA personnel on assessing compliance with the streamlined approach to cGMP compliance. The manual notes that it does not cover inspections for combination products for which CBER is the lead Center, and does not apply to facilities that make either only one type of the constituent part of a combination product or only components of constituent parts.

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