Drugs

2018 Drug Trials Snapshot Summary Out

CDER has released its 2018 Drug Trials Snapshot Summary Report, highlighting 59 novel drugs and the extent to which their safety and efficacy data was based on demographic factors. The document says the snapshots posted throughout the year provide information on the diversity of participants in clinical trials and the extent to which safety and efficacy data is based on factors such as sex, age, race, and ethnicity.

The snapshots are posted online in a standardized format after approval of a novel drug that is either a new molecular entity or an original biologic. They show who participated in the pivotal clinical trials used to approve the drug and stratify the data by sex, race, age, and ethnicity subgroups. They also provide statements on whether there were any observed differences in safety and efficacy by demographic subgroups at the time of approval.

The summary contains an overall average of each demographic group followed by a more detailed table of the percent representation of sex, race, age, and ethnicity participating in the clinical trials used to approve the drug.

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