Under the latest PDUFA, the FDA has five new criteria for choosing facilities to inspect – are you more likely to be inspected? Do your plans for dealing with drug shortages satisfy the new PDUFA requirements? How about your supplier quality agreements? Your facility registration? Your fast-track NDA? Your . . .
It would take weeks to read and digest the regulatory changes drugmakers face under the new PDUFA law — changes that may upend the way you do business. With some of the changes going into effect this year, you won’t want to wait that long.
Every five years, Congress reauthorizes the PDUFA law. In doing so, it not only raises the user fees drugmakers pay the FDA, it also lays out a long list of marching orders for the agency. The list includes:
Don’t waste countless hours researching all the changes PDUFA has in store for your business. We’ve done the work for you with PDUFA V: A Drugmaker’s Guide to Provisions in the New Law.
PDUFA V: A Drugmaker’s Guide to Provisions in the New Law is available in print or PDF format for $377 each.
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