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TGA articles

Recall - error in dosage/administration instructions

The TGA has introduced changes to help bring Australian medicine labels up to date and align them with international best practice.

Presentations given at 2017 Pharmaceutical Society of Australia Conference (PSA17), 30 July 2017

Updated guidance on GMP Clearance processes & new GMP Clearance Application Assistance Tool (CAAT)

AU eCTD Module 1 and regional information: update to the specification

Suspension of supply - user interface failures and inadequate ventilation specifications

Safety alert - Body Con Plus capsules

Safety Alert - 7-Day Slim Extreme capsules

Recall - potential for over-delivery of insulin and risk of hypoglycaemia

Interim decisions and invitation for further comment. Closing date: 3 October 2017