Drugs

More Unannounced Foreign Inspections Coming

FDA says it will expand unannounced inspections at foreign manufacturing facilities that produce medical products, drugs, and food intended for U.S. consumers and patients. A 5/6 statement says the intent is to “ensure that foreign companies will receive the same level of regulatory oversight and scrutiny as domestic companies.”

Agency commissioner Martin Makary is quoted in the statement as saying, “For too long, foreign companies have enjoyed a double standard — given advance notice before facility inspections, while American manufacturers are held to rigorous standards with no such warning. That ends today. This is a key step for FDA as part of a broader strategy to get foreign inspections back on track.”

The statement also says FDA will evaluate its policies and practices for improvements in the foreign inspection program to ensure that it is the gold standard for regulatory oversight. The changes are said to include clarifying policies for agency investigators to refuse travel accommodations from regulated industry, including lodging and transportation arrangements, to maintain the integrity of the oversight process.

FDA conducts about 12,000 domestic inspections and 3,000 foreign inspections annually in 90 countries, the statement says. While U.S. companies have frequent unannounced inspections, foreign firms often have had weeks to prepare, undermining the integrity of the oversight process, the statement says. “Despite the advanced warning that foreign firms receive,” it says, “FDA still found serious deficiencies more than twice as often than during domestic inspections.”

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