Module 16 2022

02/09/2022

Interaction with Regulators

FSCA and labelling changes may require regulatory and/or notified body interaction

No relief under strict liability for companies attempting to recall/withdraw product or change labelling

Reduces risk of liability under negligence

Changes to labelling prior to formal approval?

The Organisation for Professionals in Regulatory Affairs

15

15

Defensive Documentation

Merrill Lynch

Ford Motor Company

The Organisation for Professionals in Regulatory Affairs

16

16