Data Integrity and Form 483 or Warning Letters
Data integrity is an essential component of both clinical and nonclinical research conducted under the supervision of the Food and Drug Administration.
Review of FSVP Part 2: The Basic Mechanics of a FSVP
Food Court continues its series discussing the new Foreign Supplier Verification Program (FSVP) rule issued by the US FDA under the Food Safety Modernization Act…
Review of Proposed Rule for Foreign Supplier Verification Program Review: Part 1 – The Aim and Purpose of Animating the Rule
The US Food and Drug Administration announced the long-awaited Foreign Supplier Verification Rule (FSVP) under the Food Safety Modernization Act (FSMA) on Friday (see our…
Proposed Foreign Supplier Verification Rule under FSMA Released by FDA
The US Food and Drug Administration issued the long delayed and much anticipated Foreign Supplier Verification Rule under the Food Safety Modernization Act (FSMA) today….