Drugs

FDA Inspection Efficiency Measure Drops

FDA says that in FY 2020, the percentage of regulatory actions for OAI (official action indicated) drug manufacturing facilities completed within six months of inspection closing dropped to 63% from 74% in FY 2019. In both fiscal years, the performance measure for issuing a final facility classification letter within 90 days of inspection closing was 87%.

The performance measures were established under a 2017 Concept of Operations agreement developed by CDER and the Office of Regulatory Affairs to more effectively manage the growing complexity of the pharmaceutical landscape and to meet new challenges.

The FY 2020 summary says that from 3/2020, the Covid-19 pandemic affected the day-to-day operations at FDA and Covid-19 travel restrictions postponed non-mission-critical facility inspections.

Access the FY 2019 summary here.

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