FDA Law Blog

MAY 20, 2021

Investigators likely consult with DEA headquarters about the registrant’s compliance with required reporting and review its registration category, status, and authorized controlled substances to assess whether it may be conducting unauthorized activities. Accountability Audit. They also review CSOS transactions for completeness and accuracy.

Management 40

Management Consulting Provider Physicals 40

FDA Law Blog

MAY 20, 2021

Investigators likely consult with DEA headquarters about the registrant’s compliance with required reporting and review its registration category, status, and authorized controlled substances to assess whether it may be conducting unauthorized activities. Accountability Audit. They also review CSOS transactions for completeness and accuracy.

Management 40

Management Consulting Provider Physicals 40

FDA Law Blog

JULY 7, 2024

Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R.

Manufacturing 64

Manufacturing Provider Physicals Electronics 64

FDA Law Blog

JANUARY 8, 2023

The Act requires DEA, in consultation with HHS, to assess annually whether an adequate and uninterrupted supply, down to specific strains, exists and to establish sufficient quotas to ensure an uninterrupted supply. Cannabis Manufacturer Registration for Research. Adequate and Uninterrupted Supply of Cannabis. Application Process.

Medical 64

Medical Manufacturing Electronics Provider 64