Devices

7 Topics Discussed at 2nd MDUFA 5 Reauthorization Meeting

At the second MDUFA 5 reauthorization meeting between FDA and industry, held on 3/17, seven items were discussed. A meeting summary lists the items as:

Stakeholder feedback on MDUFA reauthorization from a 10/27/20 public meeting;
FDA perspective on MDUFA 4 performance, noting that the agency disagrees with industry’s characterization of aspects of FDA’s MDUFA 4 performance as “not being met or unlikely to be met;”
MDUFA 4 financial information with an overview of total user fee target revenue across agency user fee programs that reported that while MDUFA 4 provided a meaningful increase in funds for the program, the combined total of user fees contributing to the human drugs program is more than seven times higher;
FDA overview of digital transformation that described the current information technology infrastructure as outdated, fragmented, and inefficient and said the aging system has been slowing the regulatory process;
Fully-loaded FTE (full-time equivalent) cost model methodology;
Industry perspective on reauthorization stating these objectives and principles for MDUFA V: (1) timely patient access to safe and effective products; (2) identification of mutual goals and process improvements to achieve timely patient access; (3) retaining congressional appropriations as the primary source of CDRH funding, with user fees as additive; and (4) using fees solely for the premarket review process, and (5) recognition that industry has made significant and material investments under MDUFA 1-4; and
FDA overview on recruitment and retention outlining efforts to address hiring challenges from FY 2018 and 2019.

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