Inspections and Audits

FDA to Recognize GMP Inspections From Eight EU Countries

The FDA will begin to recognize manufacturing facility inspections conducted by drug regulatory authorities in Austria, Croatia, France, Italy, Malta, Spain, Sweden and the U.K as capable of meeting the agency’s requirements, as part of 1998 agreement between the U.S. and the European Union renegotiated earlier this year. Read More

FDA Highlights ConOps Progress at FDLI Conference

ORA and CDER officials provided an update on the agency’s Concept of Operations initiative in a Thursday panel discussion at the FDLI’s Enforcement Litigation and Compliance Conference in Washington D.C., detailing the next steps in implementing the concept. Read More