On Feb. 7, CMS posted a notice that it will begin accepting registrations for Sunshine Act aggregate-spending reports from industry on Feb. 18. Agg-spend reporting obliges the life sciences industries and GPOs to report payments offered to physicians. Additional data elements will be accepted in May, and all data will be made public later this year. Details at http://content.govdelivery.com/accounts/USCMS/bulletins/a3f695?reqfrom=share.
Understanding the FDA's Exemption for DSCSA Compliance
November 12th 2024In the quest for achieving full traceability, the exemption applies to certain trading partners under the Act, and postpones enforcement of final compliance requirements while acknowledging progress and ongoing challenges.