Drugs

OND Met, Exceeded PDUFA Goals Amid Covid-19 Work: Report

The inaugural annual report for the reorganized CDER Office of New Drugs (OND) says OND was able to meet or exceed its PDUFA goals, approve 53 new drugs, publish 31 new guidances, and maintain regulatory and programmatic operational responsibilities despite a significantly increased workload associated with the Covid-19 pandemic. The report says the additional workload included reviewing submissions for potential Covid-19 related therapies, answering inquiries from external stakeholders, and addressing various policy issues.

“Covid-19 threatened to disrupt numerous ongoing clinical trials for other indications, so OND divisions worked quickly with sponsors to manage and modify those trials to ensure they could continue in a new, largely virtual environment,” the report says.

OND Policy led the development of the Coronavirus Treatment Acceleration Program, FDA’s special emergency program to explore and determine possible coronavirus therapies. As of 12/21/20, OND reviewed over 320 trials for potential Covid-19 therapeutics and over 570 drug development programs in the planning stages.

Looking ahead, the OND report says that while the 2020 Covid-19 challenges will continue into 2021, with the end of the pandemic in sight, other challenges will come into play.

“We have already seen greater focus on development for rare diseases or disease subtypes shifting away from larger programs targeting common, chronic diseases,” the report says. “Such a shift raises the need for new approaches to development, the need for new development tools, and new policy challenges. New platforms for drug development … will also pose the need for new tools, guidances, and knowledge. The rise in interest in real-world data and evidence to support regulatory decision-making means OND, along with many other CDER offices, must gain additional experience to understand where and how such information can be appropriately used. The role of patients in drug development is also, appropriately, increasing.”

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