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.
Knowledge Center
Explore our library of blogs, short videos, virtual event recordings and training topics
Pharmaceutical and Cosmetics
Recent Blogs
LexisNexis® Reed Tech™ and ONIX Life Sciences Expand Strategic Alliance to Guide Pharma Customer to Market Faster
HORSHAM, Pa., February 14, 2023 /PRNewswire/ LexisNexis Reed Tech has teamed up with ONIX, a boutique regulatory...
MoCRA: The Future of Cosmetic Regulations
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was signed into law on December 29, 2022. This law, which provides a major overhaul of existing cosmetic regulations, requires the Food and Drug Administration (FDA) to create Good Manufacturing Practices for all cosmetics manufacturers. The law states that these established practices must include mandatory reporting of serious adverse health events caused by cosmetic products and mandatory testing of asbestos levels. This law will also include updates to cosmetic listing requirements.
Missed FDA Annual Deadlines? It’s not too late to keep your drug active!
The Food and Drug Administration (FDA) requires drug manufacturers to keep their listings updated each year....
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...
Combination Products: Regulatory Requirements and How To Comply
Combination Products continue to be at the forefront of regulatory chatter. Our customers, both medical device and...
What’s Been Happening with Health Canada XML PM Mandates?
Reed Tech recently presented a webinar to update customers with the most recent information about XML product...
DIA Global Labeling Takeaways: Patient Materials and Health Literacy
Reed Tech habitually attends industry conferences and forums to share our expertise and gain knowledge from our...
LexisNexis® Reed Tech™ and Schlafender Hase® Alliance Provides Mutual Customer Benefits for Pharmaceutical and Medical Device Companies
HORSHAM, Pa., April 26, 2022 /PRNewswire/ -- Reed Technology and Information Services Inc. (Reed Tech™), a...