Drugs

Improve Mfg. Deficiencies to Boost ANDA Approval: FDA

An FDA analysis finds a first-cycle approval rate of 13% for modified release tablet ANDAs submitted between 2017 and 2019. “Deficiencies identified in multiple review disciplines are responsible for the low first-cycle approval rate,” a CDER chart says. “Most of the cited manufacturing process-related deficiencies are unit operations. Avoiding the most common manufacturing deficiencies can improve the quality of applications, which can improve the first-cycle approval rate.”

The chart shows that 1,285 manufacturing-related deficiencies were cited during the first review cycle, including 275 cited in the complete response letter. In the 87% of the 186 modified-release tablet ANDAs studied that were issued a complete response letter, 51% of the applications were cited with process inadequate recommendations and 33% of applications were cited with facility inadequate recommendations. Some 90.7% of the complete response applications were caused by multiple review disciplines being inadequate.

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