Drugs

Stakeholders Back Meeting Pilot Program

Pharmaceutical Research and Manufacturers of America (PhRMA) says an FDA complex innovative trial design (CID) pilot meeting program “should help to promote the regulatory acceptance of and agreement on CIDs that support regulatory decision-making across review divisions.” In a comment letter, the association recommends that the agency establish a pilot selection process that includes the biostatistics pilot leadership team as well as the individual review divisions, particularly the signatory authority within the divisions, to ensure alignment and agreement of CID approaches. PhRMA also provided recommendations on several issues that it says would provide greater clarity to pilot participants and facilitate a better understanding and utilization of CID approaches in drug development.

The Biotechnology Innovation Organization (BIO) said it supports the pilot’s goal to facilitate and advance the use of complex adaptive, Bayesian, and other novel clinical trial designs. “BIO believes that the work CDER and CBER are doing to better understand and utilize complex innovative trial designs is of great importance to patients and sponsors alike,” the comment says.

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