FDA Policy/General

FDA Sees 2015-16 Regulatory Science Progress

The FDA 2016-16 Regulatory Science Progress Report, required under the FDA Safety and Innovation Act, cites gains it says it has made in a number of areas:

Advancing the Science of Medical Product Development and Evaluation through development of computational tools supporting nonclinical evaluation of medical products;
Improving Clinical Evaluation through statistical assistance in designing trials of antibiotics that could evaluate factors related to development of resistant organisms;
Advancing Product Manufacturing and Quality by developing in-house laboratory and computational capability for studying continuous manufacturing with an advanced process control system;
Ensuring the Safety and Effectiveness of Marketed Medical Products through expansion of the Sentinel system and work to develop a national evaluation system for health technology;
Advancing Regulatory Science to Promote Global Health through development of tools, reference materials, and publication of science-based guidance to support rapid development of new medical products to diagnose, treat, or prevent diseases caused by pathogens such as Ebola and Zika; and
Infrastructure Development and Organizational Changes to Advance Regulatory Science through enhancing information technology tools that support scientific review of regulatory applications.

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