Drugs

Most Post-Approval Studies ‘On Track’: Stein

CDER Office of New Drugs deputy director Peter Stein says it is important for the public to know that most drug post-approval studies are on track. “When studies are delayed,” he says in an FDA Voice blog post, “FDA works with manufacturers to identify the reasons for the delays and ensures that the studies are completed in a timely way. These post-approval studies are vital to enhancing patient safety and public health. The results from completed studies provide additional information that can lead to safety labeling changes, support expanded use of a drug, or alleviate concerns about a potential drug risk. FDA will continue to work to ensure post-marketing requirements (PMR) and post-marketing commitments (PMC) are conducted as promptly as possible.”

According to Stein, FDA issues each year a report on the status of PMRs and PMCs. He says the most recent report showed that overall, the majority of PMRs and PMCs are progressing toward completion according to the original agreed-upon schedule (85% of PMRs and 77% of PMCs).

In addition, FDA informs Congress on the status of the PMR and PMC backlog. Stein says that the report covering FY 2016 showed that the number of open PMRs and PMCs in the backlog has dropped from 1,636 to 143.

“Many factors influence the timely conduct of a study including low use of a product or changes in the standard of care which can reduce the number of patients that can be studied,” Stein writes. “FDA assesses the justification for any delays and if the justification is appropriate, monitors adherence to a revised timetable. The agency can also take enforcement actions if a post-marketing requirement is not met or, depending on the violation, may give a manufacturer the opportunity to voluntarily take prompt, corrective action.”

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