Drugs

Concerns About FDA QMM Program

The Association for Accessible Medicines (AAM) says that while it recognizes FDA’s significant efforts and investments to design a quality management maturity (QMM) program, it and its members have questions and concerns about the design and planned implementation of the program. In its comment letter, AAM raises these issues:

it remains unclear whether the agency’s planned QMM assessments will result in accurate, meaningful, objective, measurable, and helpful QMM evaluations or ratings;
FDA should more clearly clarify and substantiate how it expects the program to reduce drug shortages;
it remains unclear how FDA will be able to separate QMM assessments from its evaluation of current good manufacturing practice reliance;
it remains unclear how QMM evaluations would not be affected by establishment size or age, or the types or number of products produced;
it is unclear whether FDA has the requisite expertise and staff at this point to implement a QMM program at scale;
QMM evaluation ratings and reports should remain private for the foreseeable future;
FDA should rely primarily on third-party contractors to conduct on-site QMM evaluations;
FDA should, for the foreseeable future, not use QMM evaluations in deciding which establishments to inspect; and
FDA should clarify how it would protect trade secret and confidential commercial information acquired through the QMM process.

In its comment, Lonza thanks FDA for soliciting comments and responds to the agency’s questions.

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