Drugs

FDA OKs 4 More EU Countries for Drug Inspections

FDA has confirmed the capability of four additional European Union (EU) countries to conduct good manufacturing practice (GMP) drug inspections under the mutual recognition agreement between FDA and the EU. The addition of Czech Republic, Greece, Hungary, and Romania brings to 12 the list of EU member states whose results FDA can rely on to replace its own inspections.

The European Medicines Association says plans for the agreement to be operational in all EU member states by 7/15/2009 are on track. “The agreement is underpinned by robust evidence on both sides of the Atlantic that the EU and the U.S. have comparable regulatory and procedural frameworks for inspections of manufacturers of human medicines,” a EU statement says. “Teams from the European Commission, EU national competent authorities, the European Medicines Agency, and FDA have been auditing and assessing the respective supervisory systems since 5/2014, and are working closely together to reach the agreement’s milestones.”

In 6/2017, the European Commission confirmed that FDA has the capability, capacity, and procedures in place to carry out GMP inspections at a level equivalent to the EU. Since 11/1/17, EU member states have been able to rely on inspection results from FDA to replace their own inspections. On that same date, FDA confirmed the capability of Austria, Croatia, France, Italy, Malta, Spain, Sweden, and United Kingdom to conduct GMP inspections at a level equivalent to FDA.

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