Knowledge Center
Explore our library of blogs, short videos, virtual event recordings and training topics
Recent Blogs
Health Canada Now Requiring Second-Language at Post-Authorization Phase
Effective March 10, 2023, Health Canada changed submission requirements for second-language product monographs for human drugs. This change no longer requires the second language product monograph at the time of submission filing or review. However, both English and French languages need to be on the Drug Product Database (DPD) online and Drug and Health Product Portal (DHPP).
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.
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 overhauls existing regulations, mandating FDA-established Good Manufacturing Practices for cosmetics manufacturers.
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 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.)
Combination Products: Regulatory Requirements and How To Comply
Continue to be at the forefront of regulatory chatter. Our customers, both primarily medical device and primarily pharmaceutical, are regularly coming to us with questions surrounding this topic. Reed Tech answers these questions here in this blog post
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...