Drugs

NIH Streamlines IRB Multi-Site Policy

The National Institutes of Health (NIH) says that its new Policy on the Use of a Single Institutional Review Board (IRB) for Multi-Site Research “sets the expectation that multi-site studies conducting the same protocol use a single IRB to carry out the ethical review of the proposed research.” A statement (contains link to policy) on the policy issued by NIH director Francis Collins says that the time it takes today to go from a sound research idea to the launch of a new multi-site clinical study is too long. And, he says, a major contributor to the delay is that too many IRBs are reviewing the protocol and consent documents for the same study, often with no added benefits in terms of protecting research participants.

Collins writes that the new policy “seeks to end duplicative reviews that slow down the start of the research. NIH will support applicant and awardee institutions as they implement the new policy with guidance and resources, such as a model authorization agreement (link in statement) that lays out the roles and responsibilities of each signatory, and a model communication plan that identifies which documents are to be completed and when.”

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