Drugs

FDA Publishes Drug Filing Checklists to Avoid Delays

To increase transparency and reduce the prevalence of drug regulatory filing deficiencies, FDA has made public the filing checklists CDER uses to determine if a submitted application is complete and reviewable. An agency statement notes that filing deficiencies consume resources and delay promising treatments.

“Drug applications should not be derailed or delayed by preventable procedural oversights,” says FDA commissioner Marty Makary in the statement. “Making these checklists public is a common-sense step to make the FDA process easier to understand and more transparent.”

The statement explains that when an NDA or BLA is submitted to CDER, there is an initial filing period during which staff from each review discipline use specific checklists to assess whether the application is complete and reviewable. While small deficiencies may be quickly remedied with the sponsor, it says, the agency will refuse to file (RTF) applications with more significant deficiencies, generally forcing the sponsors to resubmit a complete application. Moving forward, it says, sponsors will be able to see a checklist for each review discipline performing a filing review.

Over the last 10 years, FDA says, over 200 applications to CDER have resulted in an RTF notification. It reports that applications involving a new molecular entity that receive an RTF experience an average delay of 426 days before application resubmittal.

The statement cautions that the checklists are not necessarily comprehensive and only the agency can determine whether an application can be filed, following applicable legal and scientific standards.

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