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FDA's 21st Century Cures Plan Gives Patient-Focused Drug Development A Boost

 
• By Sue Sutter

US agency will hold five workshops and develop seven guidance documents focused on patient input in the drug development and review process; since some guidance requirements under Cures law overlap with those in PDUFA VI commitment letter, most of the funding will come from user fees.

FDA entrance sign 2016

FDA's plan for issuing the patient-focused drug development guidance documents required under the 21st Century Cures Act includes numerous public workshops and a slightly more aggressive timeframe for some draft guidances than required under the pending agreement to reauthorize the Prescription Drug User Fee Act (PDUFA VI).

In total, the schedule FDA lays out in its "Plan for Issuance of Patient-Focused Drug Development Guidance Under 21st Century Cures Act" calls for five public workshops through December 2019 and seven draft guidances through June 2020, with

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EU Health Data Space May Speed Up R&D Through Access To Multi-Omics & Clinical Record Data

 
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The European Health Data Space framework will allow companies to accelerate R&D processes and identify new molecular targets faster by facilitating centralized access to certain types of high-quality data, Finland’s Orion Pharma says.

EU Wants Industry To Define ‘Trade Secrets’ Under Health Data Sharing Regulation

 
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EU Pharma Reform: Exclusivity Vouchers Alone Are Insufficient Incentive For Antimicrobials, Industry Says

 
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Switzerland Simplifies Imports Of Unauthorized Drugs To Tackle Drug Shortages

 
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Swiss authorities have introduced temporary measures that will make it easier for health care professionals to import medicines that are either not authorized or not available in Switzerland, which will particularly benefit pediatric drugs, in light of ongoing shortages.

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Recent and Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

UK Health Data Research Service Looks ‘Encouraging’ For Industry, But Implementation Details Will Be Key

 
• By Anabel Costa-Ferreira

Marcus Vass and Vladimir Murovec of international law firm Osborne Clarke tell the Pink Sheet what the government's planned HDRS might mean for industry, and how it compares with the European Health Data Space.

EU Health Data Space May Speed Up R&D Through Access To Multi-Omics & Clinical Record Data

 
• By Eliza Slawther

The European Health Data Space framework will allow companies to accelerate R&D processes and identify new molecular targets faster by facilitating centralized access to certain types of high-quality data, Finland’s Orion Pharma says.