An important step forward in the global harmonisation of premarket review programmes.
The United States Food and Drug Administration (FDA) has announced its intention to launch an extraordinary new pilot programme that could have a significant effect on efforts to harmonise premarket review procedures worldwide. This article discusses the programme and the importance of submitting comments to FDA on this new initiative.
Donawa
M
M
donawa@srd.it
D000818:Animals; D001315:Australia; D002170:Canada; D018795:Device Approval / Q000331:legislation & jurisprudence* / Q000592:standards*; D019544:Equipment Failure Analysis / Q000379:methods / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D005062:European Union; D006801:Humans; D010865:Pilot Projects; D014481:United States; D014486:United States Food and Drug Administration