Module 1 2021

28/06/2021

USA legislation–medicinal products

No SME “status” or overt benefits CDER's Small Business and Industry Assistance (SBIA) Program • Office of Training and Communication • Small business assistance bulletin • Answer queries • Orphan drug programme (grants/tax credits) • PDUFA – waivers/reductions in fees in some cases

The Organisation for Professionals in Regulatory Affairs

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Comparison SME vs Big Pharma

• Difference to Big Pharma? • NO - content • Regulatory procedures the same except SME advantages • Data package requirements the same • YES - timing

• Big Pharma – driver - time to market • SME – driver - often financial resources

The Organisation for Professionals in Regulatory Affairs

14

7