Knowledge Center

Explore our library of blogs, short videos, virtual event recordings and training topics

Recent Blogs

Simplifying Annual Drug Sample Reporting
Simplifying Annual Drug Sample Reporting

Pharma manufacturers and authorized distributors need to submit distribution reports electronically in an eXtensible Markup Language (XML) format to comply with the guidance entitled Reporting Drug Sample Information Under Section 6004 of the Affordable Care Act. This guidance fulfills the Drug Sample Transparency Act specification of ACA Section 6004. These amounts must be reported each year by April 1st for the previous calendar year.

read more
New FDA Requirement: New and Updated REMS Files to be Submitted in SPL Format
New FDA Requirement: New and Updated REMS Files to be Submitted in SPL Format

As of December 28, 2022, all new REMS (Risk Evaluation and Mitigation Strategy) submissions and all REMS updates will be required to be submitted in SPL (Structured Product Labeling) format per the FDA. This is in compliance with the Final Guidance on REMS issued by FDA in late December 2020. This means that any current REMS registrations will not need to be submitted in SPL until they require updates. There are currently 62 active REMS—58 ETASU (Elements to Assure Safe Use) and 4 basic (non-ETASU.)

read more