Drugs

Public Meeting Seeks Priorities for New Drug Review

FDA says it is planning an 11/7 public meeting on “Promoting Effective Drug Development Programs: Opportunities and Priorities for FDA’s Office of New Drugs” to obtain “actionable policy suggestions“ for CDER review staff “regarding opportunities to promote effective drug development while maintaining the FDA’s regulatory standards for the assessment of safety and effectiveness of new drug products.” An FDA notice says CDER Office of New Drug leaders are interested in input on:

Areas where OND can provide additional guidance or prioritize additional scientific discussion to improve clarity and encourage effective drug development,
Suggestions for guidance or policy development to facilitate drug development for diseases or conditions not currently amenable to targeted therapies,
Advantages and disadvantages of extending novel trial designs to a wider range of therapeutic areas,
Areas where further clarity of FDA’s current thinking may be useful to address variability across divisions and
Recommendations for how to promote effective drug development programs while managing the tension between innovation and the uncertainty it can introduce.

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