Drugs

Pediatric GERD Drug Development Guidance

FDA has issued a draft guidance, Pediatric Gastroesophageal Reflux Disease: Developing Drugs for Treatment, to help sponsors in clinical development of drugs for treating gastroesophageal reflux disease (GERD) in the pediatric population of infants, children, and adolescents. Specifically, the document addresses the agency’s current thinking regarding clinical presentation by age and disease, study populations, endpoints, and clinical pharmacology issues affecting dosing. “This draft is intended to serve as a focus for continued discussions among the Division Gastroenterology and Inborn Errors Products, pharmaceutical sponsors, the academic community, and the public,” it says.

Sponsors, the guidance says, are encouraged to discuss the specifics of podiatric programs as early as is feasible with the division on a case-by-case basis because sponsors are required to submit pediatric study plans under the Pediatric Research Equity Act no later than 60 days after an end-of-phase 2 meeting

The guidance covers Background of Pediatric GERD, Drug Development Strategy: Paradigms and Regulatory Considerations, Clinical Trial Design Considerations, and References.

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