Devices

Stakeholders Disagree with Parts of GLP Proposal

Pfizer says that while it agrees that the current good laboratory practice (GLP) regulations need to be modernized, it does not agree that the conduct of certain early stage safety or efficacy studies needs to be done in accordance with GLP. Responding to an FDA proposed rule, the company says it welcomes some positive changes in the rule, but still has concerns in five broad areas: the regulations’ scope, the sections on animal welfare, quality assurance unit roles and responsibilities, incomplete alignment with the Organization for Economic Cooperation and Development (OECD), and administrative burden and unnecessary complexity.

Sanofi’s comment letter says that although the proposal includes some harmonization of definitions with the current OECD GLPs, many definitions have been added that are not consistent globally and may affect compliance in terms of global, multi-site studies.

In its response, Merck says it is concerned that, as written, the proposed requirements place unnecessary burdens on industry by introducing redundancies and administrative steps that it says do not contribute to data quality or integrity. “Further,” the company says, “we suspect that the time and cost estimates contained in the docket are underestimated and do not reflect the true economic impact of the proposed changes.” The company suggests that FDA hold a public workshop on the proposal to clarify the potential impact through closer collaboration with affected stakeholders.

Finally, AdvaMed asks that the agency keep provisions of the 21^st Century Cures Act in mind and ensure that the proposed rule is consistent with that law’s requirements. It also asks FDA for an idea on when a final rule might be released, and asks it to provide appropriate training to agency field inspectors to ensure that they are knowledgeable in the rule’s specific requirements before conducting inspections.

All four stakeholders also provide lengthy, specific comments on the proposal.

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