The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
Sen. Edward Kennedy (D-Mass.) introduced the Prescription Drug User Fee Act (PDUFA) reauthorization last week, proposing a new structure that would increase the agency's user fees by more than $100 million.
A new analysis of previously conducted studies showed no increase in coronary heart disease for women in their 50s who take hormone therapies close the start of menopause, according to an article in The Journal of the American Medical Association (JAMA).
The FDA added noncompliance with regulations covering submissions of postmarketing adverse event drug reports to the list of reportable Form 483 observations that should be cited during FDA inspections, according to the 2007 Investigations Operations Manual (IOM).