Drugs

FDA Should Address Approval Rate Factors: GAO

The Government Accountability Office (GAO) says FDA should take additional steps to address factors that may affect approval rates of generic drugs in the first review cycle. A GAO report says that 12% of the 2,030 generic drug applications reviewed by FDA from FY 2015 through FY 2017 were approved in the first cycle. For applications not approved in the first cycle, it says, the application must undergo one or more subsequent review cycles to obtain approval, delaying the generic drug’s arrival to market.

GAO says it identified several factors that may have contributed to whether a generic drug was approved during the first review cycle, such as certain types of complex drugs that were less likely to receive approval in the first review cycle. The report says FDA has taken steps to increase the rate of generic drug approvals in the first cycle, such as increasing communication with applicants and introducing templates for reviewers to improve the consistency and clarity of their comments.

GAO recommended that FDA (1) take additional steps to address inconsistency in its written comments to generic drug application sponsors; and (2) assess the extent to which the timing of branded drug companies’ drug labeling changes affects the approval of generic drugs and take steps, as appropriate, to limit the effect. FDA concurred with the recommendations.

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

Read more

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