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.
Drugmakers must dole out nearly $2 million in fees for drug applications requiring clinical data in fiscal 2013, while companies submitting applications without such data, or supplemental drug apps, will need to fork over half that amount. The fees go into effect Oct. 1. The new rates, set to publish in the Aug. 1 Federal Register, also cover establishment fees — charged to certain facilities that produce drugs — and product fees for already approved drugs. Drug Industry Daily