Drugs

FDA Inspected 739 (26%) of Non-U.S. Drug Sites

FDA says it inspected 26% (739) of the 2,852 foreign-based human drug manufacturing sites outside of the U.S. in fiscal year 2018. In a 5/17 agency post, FDA provided a glimpse into its recent drug inspection activities. “As of fiscal year 2018, there were 4,676 human pharmaceutical sites worldwide subject to routine surveillance inspection — 61% of those were foreign-based,” the post says. “For that year, the FDA conducted 1,365 human drug Current Good Manufacturing Practice (CGMP) surveillance inspections, of which 739 were conducted at facilities outside the U.S., to ensure manufacturers were following CGMP requirements and maintaining high quality standards.”

The agency recently has had to defend its oversight of the generic drug industry following media reports that have questioned their quality and safety (see earlier story). “By maintaining global vigilance over the generic manufacturing industry, in close collaboration with our international regulatory partners, FDA provides confidence in the quality of these medicines while helping patients realize more of the benefits from high quality, low cost generics,” the agency post says. “Through Program Alignment, coordination with FDA’s Center for Drug Evaluation and Research and Office of Global Policy and Strategy, as well as more global partnerships, we can continue to take enhanced steps to address the increasing challenges posed by a global supply chain and encourage the adoption of new advanced manufacturing methods. These actions are key parts of our commitment to ensure high-quality manufacturing, and to make sure Americans have confidence in the quality of products in their medicine cabinets — regardless of where they were manufactured.”

FDA notes that in the two years since Program Alignment began, agency investigators have a greater focused expertise across all products that fall under FDA’s purview, and its “regulation of generic drugs has never been stronger, more strategic, more risk-based, or more efficient than it is today.”

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