FDA Policy/General

FDA/EU MRA Now Includes Animal Inspections

FDA and the European Union have agreed to expand the scope of the U.S.-EU Mutual Recognition Agreement (MRA) Sectoral Annex for Pharmaceutical Good Manufacturing Practices (GMP) to include inspections of veterinary pharmaceuticals. Under the expanded MRA, FDA can rely on GMP inspections of veterinary product facilities conducted by the 16 EU member states and the EU can rely on inspections conducted by FDA.

“By utilizing each other’s inspection reports and related information, an MRA can ultimately enable the FDA and the EU to avoid duplication of some animal drug inspections and enable regulators to devote more resources to other parts of the world where there may be greater risk,” an FDA notice says. “Over the past several months, the FDA has taken numerous steps to prepare for expanding and implementing the MRA’s coverage to include animal drugs. Among other things, this has included sharing information with the EU about FDA’s Center for Veterinary Medicine’s oversight of animal drug manufacturing in the United States; observing EU audits of individual member states including observations of inspections conducted by EU member state inspectors; and conducting assessments of some EU member states’ regulatory frameworks, which found that these member states have the capability, capacity, and procedures to carry out routine GMP surveillance inspections that meet FDA requirements for animal drugs.”

The 16 member states are: Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Greece, Hungary, Ireland, Luxembourg, Netherlands, Poland, Portugal, Slovenia, and Spain.

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