FDA Meeting Update
IDT Australia Limited (IDT) provides the following market update regarding the meeting held with the U.S. Food and Drug Administration (FDA) in Washington on 24 July 2018.
Ms Michelle Coffey and Dr David Sparling, along with IDT’s U.S. based specialist consultants today attended a meeting with representatives from the FDA’s Office of Manufacturing Quality.
The meeting was held at the FDA’s White Oak Campus in Silver Spring, Washington Maryland.
At the meeting, IDT outlined and discussed its Remediation and Action Plan, which addresses the FDA’s concerns raised in their audit findings and the accompanying warning letter, dated 23 May 2018.
The Company briefed the FDA on the progress it has made regarding its remediation commitments to date and provided an update on its longer‐term commitments.
The dialogue during the meeting was positive and the FDA encouraged IDT to continue with its remediation plans.
Importantly IDT remains free to continue to market its products into the United States.
IDT will provide the FDA with bi‐monthly updates on its progress against the Remediation and Action Plan and will focus on preparing the facility for a re‐inspection by the FDA.