Drugs

CDER Office of Pharmaceutical Quality Meeting Initiatives: Report

The CDER Office of Pharmaceutical Quality (OPQ) says that in 2018 it worked on implementing four strategic priorities: collaboration, innovation, communication, and engagement. The OPQ 2018 annual report says it improved integration of internal processes to find more efficiencies. It also held public events to encourage quality-related innovation within FDA and established programs to engage stakeholders in discussions on further improving pharmaceutical quality.

With over 1,300 staff, OPQ is the largest office in CDER. Its role is to provide assessment, inspection, research, surveillance, and policy to assure that the American public has access to safe, effective, quality drugs. It provides the quality assessment, covering drug substance, drug product, manufacturing, and facilities, for INDs and all types of human drug marketing application.

In 2018, OPQ saw record approvals of generic drugs, biosimilar drugs, and novel drugs, the report says. Thus, there were 4,399 INDs assessed and 123 NDA approvals, 1,021 ANDA approvals, and 24 BLA approvals.

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