Drugs

Revise Anti-Infective Drug Development Outcomes: Study

Researchers from Harvard Medical School and other institutions say FDA should update and revise existing guidances for anti-infective drug approvals to recommend appropriate clinical outcomes consistent with general scientific and regulatory parameters. Writing online in JAMA Internal Medicine, the researchers say that 21 of 27 guidances reviewed recommended surrogate outcomes as either the primary endpoint or as components of composite endpoints. “None of the recommendations for the use of indirect measures matched the regulatory and scientific conditions favoring indirect outcomes in place of clinical outcomes,” the article says.

The authors say the agency guidances could be improved by:

limiting recommendations for using surrogates to certain well-defined circumstances;
reexamining recommendations for using surrogate measures in trials of infectious disease products designed with noninferiority hypotheses; and
ensuring that when surrogates are recommended, particularly surrogates that FDA regards as validated and suitable for traditional full approval, the supporting evidence is cited explicitly in the guidance.

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