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Patient-focused drug development program

Published by IRDiRC

Patient Advice Regulatory Affairs Early Access Support Patient Support Regulatory Advice Patient Focused Drug Development Programme

The Patient-focused Drug Development (PFDD) program was initiated at FDA from 2012- 2017 under Congressional Mandate (PDUFA V) to more systematically obtain the patient perspective on specific diseases and their treatments. PFDD meetings provide key stakeholders an opportunity to hear the patient’s voice.

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US Orphan Drug Designation

Published by IRDiRC

Early Access Support Orphan Drug Incentive Regulatory Advice Orphan Drug Designation Regulatory Affairs

The ODA is intended to provide incentives for Orphan Drug development and to defray the costs of qualified clinical testing expenses incurred in connection with the development of drugs for rare diseases and conditions.

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Published by IRDiRC

Regulatory Affairs Marketing Authorisation Regulatory Advice Priority Review Voucher Priority Review Designation Biologics License Application New Drug Application

A Priority Review designation results in an abbreviated PDUFA mandated goal date for a Biologics License Application (BLA) or a New Drug Application (NDA), from 10 months (under standard procedure) to 6 months.

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FDA Expedited Program for serious conditions – Special Protocol Assessment

Published by IRDiRC

Clinical Development Regulatory Affairs Clinical Trial Design Regulatory Advice Special Protocol Assessment

FDA-SPA is a process in which sponsors may ask to meet with FDA to reach agreement on the design and size of certain clinical trials, clinical studies, or animal studies, to determine if they adequately address scientific and regulatory requirements for a study that could support marketing approval.

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Patient-focused drug development program

US Orphan Drug Designation

FDA Expedited Program for serious conditions – Special Protocol Assessment

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