Drugs

CDER Sees No Negatives with Expanded Access Decisions

CDER officials say expanded access decisions have not led to a negative regulatory decision regarding a drug application, and there was only one instance where safety events under expanded access had a potentially negative effect on product labeling. “Concern that expanded access will have a negative impact on drug development and review is not based on the evidence and is unwarranted,” they write in the latest issue of Therapeutic Innovation & Regulatory Science.

The officials say that 321 regulatory approval decisions were examined by CDER and it found that 28% of the drugs had prior expanded access. “The approval rate for drugs with expanded access (84%) was higher than those that did not (76%),” they write. “None of the negative regulatory marketing decisions were based on the adverse experiences reported under expanded access. The vast majority of deaths and serious adverse events that occurred under expanded access were not interpreted by FDA to be due to the investigational drug and did not affect product labeling.”

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