Drugs

FDA, Switzerland Recognizing Each Other's Inspections

FDA and Switzerland 7/27 have entered into a mutual recognition agreement (MRA) where each regulatory agency can rely on the other’s factual findings from a good manufacturing practice (GMP) inspection of a pharmaceutical manufacturing facility. The regulatory agencies signed the agreement 1/12, but it was contingent on FDA determining that Swissmedic is capable of conducting inspections that meet U.S. requirements, and Swissmedic had made a similar determination with respect to FDA. “Both agencies have now completed those determinations based on the criteria and procedures outlined in the MRA and recognized each other under the MRA,” an FDA notice says.

In addition to covering GMP inspections of facilities making human drugs, the MRA covers veterinary drugs. “MRAs are also in effect with the European Union and the United Kingdom,” the agency says. “MRAs are an effective tool in today’s global pharmaceutical market, allowing the FDA to work more efficiently and maximize its resources. Over 250 pharmaceutical companies are based in Switzerland, ranging from start-ups all the way to multinationals, according to Swissmedic, which has issued manufacturing licenses to approximately 370 sites across the country.

“Sharing information will help the FDA and Swissmedic avoid the duplication of drug inspections, lower inspection costs and enable regulators to devote more resources to other parts of the world.”

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

Read more

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