Drugs

PhRMA Raises QMM, KASA Issues

Responding to an upcoming FDA Pharmaceutical Science and Clinical Pharmacology Advisory Committee meeting to discuss CDER’s Quality Management Maturity (QMM) and Knowledge-Aided Assessment and Structured Application (KASA) programs, Pharmaceutical Research and Manufacturers of America (PhRMA) says it has issues that it would like to be considered by the committee. The industry association comment letter says PhRMA recommends that FDA confirm that any QMM program it develops would be voluntary.

Further, it says, under any voluntary program FDA should make clear that any QMM-related value or score would not be publicly disclosed, including rankings or comparisons among and between firms. PhRMA says manufacturers could voluntarily disclose such ratings to appropriate stakeholders such as purchasers in the normal course of business.

The letter contains other comments and suggestions on the QMM program and then expresses significant concerns about implementing KASA for innovative products. “It is not apparent, for example, how KASA’s structure can support risk/benefit decisions regarding new molecular entities,” the letter says. “Moreover, it remains to be seen how KASA will support existing and planned harmonized data submission formats. Maintaining interoperability with global data standards is paramount for a successful data submission program.”

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

Read more

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