Drugs

FDA Posts Drug User Fee Commitment Letter

FDA has posted the commitment letter (performance goals and procedures) from industry negotiations to reauthorize the Prescription Drug User Fee Act for fiscal years 2018 through 2022. The letter outlines the agency intention to enhance regulatory science and expedite drug development. “To ensure that new and innovative products are developed and available to patients in a timely manner, FDA will build on the success of the FDA’s regulatory science program that included advancing the science of meta-analysis methodologies, advancing the use of biomarkers and pharmacogenomics, enhancing communications between FDA and sponsors during drug development, and advancing the development of drugs for rare diseases,” FDA says. “The extension and continuation of this work will encompass further evaluation and enhancement of FDA-sponsor communications, ensuring the sustained success of the breakthrough therapy program, establishing early consultations between FDA and sponsors on the use of new surrogate endpoints as the primary basis for product approval, advancing rare disease drug development, advancing the development of combination products, and exploring the use of real world evidence for use in regulatory decision-making.”

Another focal area is to improve the timely interactive communication with sponsors during drug development. For example, FDA has agreed to contract with an independent third party to assess current practices of agency/sponsor in communicating during drug development. “The third party will be expected to separately engage both FDA staff and individual sponsors through contractor-led interviews as part of the assessment,” the letter says. “The third party will identify best practices and areas for improvement in communication by FDA review staff and sponsors.” FDA will publish a final report on its Web site no later than the end of 2020.

FDA also agreed to convene a public workshop in 2021 to discuss the assessment’s findings, including anonymized, aggregated feedback from sponsors and FDA review teams resulting from the contractor interviews. Recommendations for best practices will be incorporated into a guidance on “Best Practices for Communication Between IND Sponsors and FDA During Drug Development,” the letter 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

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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