all of the pathways / tools to a faster approval:
here are most of the pathways / tools available - i say most because i may have missed some.
FIRST DRAFT. please chime in with corrections additions. more detail on these coming, just wanted to get this going so people can enjoy, attack, whatever and help make this more complete later on.
*** three asterisks means i consider it relevant for cytodyn
designations that bring the fda into close regular contact with the company in order to move things along faster throughout the development process, not only the approval process:
these three designations aren;t directly about speed, but carry other important incentives
rare pediatric
orphan drug (targeting < 200,000 patients)
QIDP (similar to orphan drug, for Antibacterial and Antifungal Drugs)
these three designations are about speed
***fast track (usually applied for earlier than btd, but can be applied for concurrently as a backup plan, or after btd rejection)
***breakthrough designation (all fast track elements plus more)
RMAT (similar to breakthrough, for cell and gene therapies)
shortened approval pathways that reduce the regulatory requirements, and or shorten the timelines, leading to the actual approval:
***CNVP (commissioner's national voucher program - *NEW)
***accelerated approval
LPAD (similar to accelerated approval, for Antibacterial and Antifungal Drugs)
***label expansion 505b1 (same company new use)
label expansion 505b2 (different company new use)
fda regulatory tools to shorten whatever pathway you are on:
***priority review (applied for upon BLA submission - shortens the final review process from 10 months to 6)
***rolling review (available with fast track, breakthru, RMAT designations, but must be requested and can be denied - not part of accelerated approval unless company also has fast track breakthru or RMAT)
***RTOR (real time oncology review) - (rolling review on steroids - requested at the end of your last trial - after database lock - pre-BLA)
>rolling review requires full BLA modules be submitted, RTOR allows you to send smaller pieces, sort of a low tech RTCT)
RTCT (real-time clinical trials - *NEW) - (RTOR on steroids - currently moving to pilot phase)
other considerations
***the I-SPY consortium (for breast cancer) - a very special case, with complexity, AND SIMPLICITY!
here are most of the pathways / tools available - i say most because i may have missed some.
FIRST DRAFT. please chime in with corrections additions. more detail on these coming, just wanted to get this going so people can enjoy, attack, whatever and help make this more complete later on.
*** three asterisks means i consider it relevant for cytodyn
designations that bring the fda into close regular contact with the company in order to move things along faster throughout the development process, not only the approval process:
these three designations aren;t directly about speed, but carry other important incentives
rare pediatric
orphan drug (targeting < 200,000 patients)
QIDP (similar to orphan drug, for Antibacterial and Antifungal Drugs)
these three designations are about speed
***fast track (usually applied for earlier than btd, but can be applied for concurrently as a backup plan, or after btd rejection)
***breakthrough designation (all fast track elements plus more)
RMAT (similar to breakthrough, for cell and gene therapies)
shortened approval pathways that reduce the regulatory requirements, and or shorten the timelines, leading to the actual approval:
***CNVP (commissioner's national voucher program - *NEW)
***accelerated approval
LPAD (similar to accelerated approval, for Antibacterial and Antifungal Drugs)
***label expansion 505b1 (same company new use)
label expansion 505b2 (different company new use)
fda regulatory tools to shorten whatever pathway you are on:
***priority review (applied for upon BLA submission - shortens the final review process from 10 months to 6)
***rolling review (available with fast track, breakthru, RMAT designations, but must be requested and can be denied - not part of accelerated approval unless company also has fast track breakthru or RMAT)
***RTOR (real time oncology review) - (rolling review on steroids - requested at the end of your last trial - after database lock - pre-BLA)
>rolling review requires full BLA modules be submitted, RTOR allows you to send smaller pieces, sort of a low tech RTCT)
RTCT (real-time clinical trials - *NEW) - (RTOR on steroids - currently moving to pilot phase)
other considerations
***the I-SPY consortium (for breast cancer) - a very special case, with complexity, AND SIMPLICITY!
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