Drugs

GAO Report Examines NDA Review Times

A new Government Accountability Act report examined 637 NDAs submitted between 2014 to 2018 and found that while the agency met its review goals, differences in review times among the review divisions were “largely driven by the characteristics of the applications being reviewed.” The government watchdog agency was tasked with examining NDA review times across FDA’s divisions, such as differences between FDA divisions in the key features of the NDAs they review and initial review times, as well as the extent to which key NDA features contribute to these differences.

The report noted four key NDA features that impacted the time it takes to complete initial reviews. These are:

Whether or not the NDA qualifies for a priority review. The user fee goal for review of a priority NDA is four months less than the 10-month standard review NDA
Whether or not it qualified for one or more of the expedited programs for drugs intended to treat serious or life-threatening conditions.
Whether or not the NDA involves a new molecular entity (NME). The user fee goal for an NDA with a new molecular entity is two months longer than for an NDA without one.
Whether or not the applicant submits a major amendment (additional or new information, such as a major new clinical study) while the NDA is under review. The user fee goal for an NDA may be extended by three months if the applicant submits a major amendment.

GAO also found that the proportion of NDAs with these key features differed among FDA review divisions. For example, 6% of the NDAs reviewed by the dermatology and dental division had a priority designation, compared to 56% for the anti-infective division. “FDA has reported that some divisions, such as the oncology divisions, generally regulate products for conditions that are more likely to be serious or life-threatening, and, therefore, those products may be more likely to qualify for priority designation and other expedited programs,” it says.

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