| 2017 |
| October | - Draft guidance for the Breakthrough
Devices Program.
|
| November | - Draft guidance for expedited programs for regenerative medicine therapies for serious conditions.
|
| 2018 |
| June | - Draft guidance for patient-focused drug development.
- Draft guidance for the Humanitarian Device Exemption program. Deadline for final guidance not specified.
|
| December | - Final guidance for the Breakthrough
Devices program.
- Framework for the Real-World Evidence Program.
|
| 2019 |
| February | - Final guidance for expedited programs for regenerative medicine therapies for serious conditions.
|
| December | - Deadline for draft guidance on the qualification of drug development tools. Deadline for final guidance is six months after the public
comment period for the draft closes.
|
| 2020 |
| June | - Deadline for revised or final guidance for patient-focused drug development.
|
| 2021 |
| December | - Deadline for draft guidance on the
Real-World Evidence Program.
- Deadline for revised or final guidance is 18 months after the public comment period for the draft closes.
|