- Updates done for re-submission on April 19th, 2024.
- Final materials submitted to the FDA-eCTD portal can be found here - https://github.com/RConsortium/submissions-pilot3-adam-to-fda/releases/tag/v2.0.0
What's Changed
- Update Latest News section of the Pilot3 Website to include the Pharm… by @robertdevine in #154
- FDA Feedback: Closes #152 Derive LOCF only considering ANL01FL=Y by @kaz462 in #146
- Remove stray newline between bullet 2 and bullet 3 in the Latest News section of the README by @robertdevine in #157
- Add Statistical Software Clarifying Statement to the Pilot3 Website homepage. by @robertdevine in #160
- Pilot3 Website Update with link to R Consortium March 2024 Meeting Minutes by @robertdevine in #164
- Pilot3 Website - Latest News Update - PharmaSUG May 2024 Baltimore by @robertdevine in #166
- 168 - namespace update by @SHAESEN2 in #169
- 156 adrg update fda feedback by @laxamanaj in #162
- Closes #170 Clean up: Removes adrg_image folder, old spec references, duplicate image, website update by @bms63 in #171
- Align lock file for .zip Installation Instructions, general cleanup by @robertdevine in #172
- updated adrg, updated renv.lock to remove pilot3utils and xportr inst… by @laxamanaj in #175
- added response letter by @SHAESEN2 in #163
- add p21 report by @kaz462 in #182
- Tidying tlf-demographic.Rmd removing {pilot1wrappers} package dependency. by @robertdevine in #178
- Tidying .Rbuildignore removing {pilot1wrappers} references by @robertdevine in #184
Full Changelog: v1.0.0...v2.0.0
Contributors
robertdevine, bms63, and 3 other contributors