Drugs

Innovative Manufacturing Workshop Positive Comments

Pharmaceutical Research and Manufacturers of America (PhRMA) says it believes the Advanced Manufacturing Technologies Designation Program discussed at an FDA 6/8 workshop on advancing the use and supporting the implementation of innovative manufacturing approaches “has the potential to further the use of advanced manufacturing technologies that can, in turn, help improve patient access to safe and effective innovative medicines.” The comment letter focuses on the efficient adoption of new technologies in pharmaceutical manufacturing. “We perceive the central challenge to be the uncertainty of global regulatory acceptance of a new process (or technology) and corresponding control strategies,” the association says.

The American Society of Gene & Cell Therapy says advanced manufacturing technologies, including platforms, could play a crucial role in streamlining the development process for cell and gene therapies where chemistry, manufacturing, and controls remains the bottleneck in cell and gene therapy development. “Greater adoption of advanced manufacturing technologies would allow developers to rely on previous data and speed the development of desperately needed therapies for populations who often have few or no treatment options by moving away from complex, bespoke manufacturing processes that inhibit the availability of drug product developers to get all patients high quality, safe, and efficacious drug products,” the society says. “In short, a regulatory process to review advanced manufacturing technologies that is clear and predictable to developers would be useful for scalability, consistency, and cost of development, among other benefits. This would increase the likelihood of translation from cell and gene therapy product development to bedside in order to ensure timely patient access.”

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