Drugs

FDA Met or Exceeded Many FY 2020 User Fee Goals

The latest annual user fee program data show the agency met or exceeded many of its goals under PDUFA and BsUFA. The report says the agency met or exceeded the performance level for 10 out of 12 review goals for FY 2020 final performance. And, it says, FDA is currently meeting or exceeding the performance level for nine out of 12 review goals for FY 2021 preliminary performance.

FDA met or exceeded the performance level for five out of six FY 2020 procedural goals and met or exceeded the performance level for three out of 14 meeting management goals. For the preliminary FY 2021 goals, it says it is meeting or exceeding the performance level for five out of six procedural goals and four out of 14 meeting management goals.

Under BsUFA, the agency met or exceeded the performance level for five out of six applications and supplements review goals for FY 2020 and is meeting or exceeding the performance level of all six FY 2021 review goals.

It met or exceeded the performance level for none of the three procedural response goals for FY 2020 and is currently meeting or exceeding the performance level for two out of three FY 2021 procedural response goals.

Finally, FDA met or exceeded performance level for eight out of 10 BsUFA meeting management goals for FY 2020 final performance and is meeting or exceeding the performance level for four out of 15 FY 2021 preliminary performance meeting management goals.

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