Drugs

Including Pregnant Women in Trials Draft Guide

FDA has posted a draft guidance entitled: “Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials.” The document provides recommendations about how and when to include pregnant women in drug development clinical trials. It also discusses the scientific and ethical issues that should be addressed when considering the inclusion of pregnant women in clinical trials.

“Because of the complex ethical issues involved in designing clinical trials that include pregnant women, sponsors should consider including an ethicist in planning their drug development programs,” the guidance says. “Moreover, sponsors should consider meeting with the appropriate FDA review division early in the development phase to discuss when and how to include pregnant women in the drug development plan. These discussions should involve FDA experts in bioethics and maternal health.”

The guidance also addresses institutional review board (IRB) oversight. “Therefore, if an IRB regularly reviews research involving pregnant women, the IRB must consider including one or more individuals who are knowledgeable about and experienced in working with such subjects (21 CFR 56.107(a)),” it says. “Additionally, IRBs are required to determine that additional safeguards are included in the trial to protect the rights and welfare of subjects who are pregnant (21 CFR 56.111(b)).”

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