Drugs

Stakeholders Comment on Breast Cancer Draft Guidance

The American College of Obstetricians and Gynecologists (ACOG) says it strongly supports the recommendation stated in an FDA draft guidance to consider including premenopausal women in breast cancer drug development programs. However, the ACOG comment letter says, it recommends expanding the guidance scope to include survivorship issues, such as fertility preservation, contraception, and pregnancy due to a lack of data to inform the provision of care. ACOG says that if FDA determines the topics are beyond the scope of this guidance, it should consider addressing them in a subsequent guidance.

The National Center for Health Research says it strongly endorses the recommendation that premenopausal women be included in breast cancer drug development programs. “ By including sufficient numbers of premenopausal women, clinical trials should provide meaningful information to women of different ages and races,” the letter says.

A comment from the Society for Women’s Health Research says that because of the poor inclusion rates for younger women in breast cancer clinical trials, treatment in that population is frequently based on studies conducted on postmenopausal patients. It thus supports the FDA recommendation to include premenopausal women in drug development programs.

Pfizer and AstraZeneca each submitted line-by-line technical comments.

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