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.

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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:

• Changes to the requirements for registration of domestic and foreign drug establishments and commercial importers
• Direction to FDA to allocate inspection funding toward registered sites with “known safety risks”
• A mandate for early drugmaker notification on manufacturing changes that could create drug shortages
• Changes to FDA’s Accelerated Approval program
• A broadened definition of current good manufacturing practices (cGMP)that will give the agency greater control over a company’s suppliers.
• Enhanced counterfeiting penalties and fines
• Changes to 180-day exclusivity for generics first filers
• Mandates for electronic submissions of INDs, NDAs, BLAs and ANDAs
• New rules expanding accelerated approvals programs for new drugs
• Changes to the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act to encourage testing of medicines in children
• Addition of incentives for manufacturing new antibiotics (GAIN Act)
• Requirement of an FDA guidance on the promotion of drugs through social media within two years of the bill’s enactment; and
• Requirement that the FDA develop a strategy and implementation plan for advancing regulatory science.
• And more.

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.

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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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