Reed Tech hosted a webinar in February 2022 to explain the new annual drug distribution report announced by the US Food and Drug Administration (FDA) in late 2021. At this time, it was understood the deadline for reporting 2020 data would be February 15, 2022. Since then FDA has explained this was a suggested deadline rather than a required deadline because the final guidance is not yet approved.
In our free webinar, Reed Tech subject-matter experts, Gary Saner and David Wilson, provided a recap of what this new deadline means for pharma companies and how to ensure compliance, as well as explained the implications of recent updates and the progress of the draft guidance. Review the recording from our webinar on Tuesday, February 1, 2022, at 2 PM ET to learn more.
- What drugs are in scope?
- When and how is drug data reported?
- What does draft guidance mean?
- What needs to be done now?
What is the new reporting requirement? According to the FDA, “Each registrant that lists a drug must report to FDA annually on the amount of such drug that it manufactured, prepared, propagated, compounded or processed (including repacking and relabeling) for commercial distribution.” As a result, this requirement will affect most of the pharmaceutical industry. There are requirements surrounding the data, the submission format, and the submission pathway that need to be understood to achieve compliance with this new requirement.
Register to review the webinar recorded on Wednesday, March 23rd at 2 PM ET and to download the slides!