Drugs

505(b)(2) Sponsors ‘May Need Less Safety Data”

Camargo consultant William Stoltman says that a recent CDER/CBER guidance on the extent of safety data collection needed in late-stage premarket and post-approval clinical investigations may provide a significant reduction in safety data collection for NDA sponsors, and especially for those using the 505(b)(2) regulatory pathway. Writing in a 505(b)(2) Blog post, Stoltman says that the guidance lists several conditions that may make selective safety data collection appropriate. It also lists the types of clinical investigations that may be considered for selective safety data collection, and the types of safety data that are candidates for selective safety data collection.

“The lynchpin to the possibility of selective safety data collection appears to be the existence of a robust safety database for the product in question,” Stoltman writes. “That is often the case with a product being developed using the 505(b)(2) regulatory pathway. By definition, an application pursuant to Section 505(b)(2) frequently relies on extensive, pre-existing safety data.”

The guidance also includes further details and conditions, the post says, the most important of which is the requirement to develop a plan and reach agreement on the specifics of a selective safety data collection with the relevant FDA review division or divisions, such as at the end-of-Phase 2 meeting before starting a Phase 3 study.

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