This notice advises of the intention of the delegate of the Minister for Health and Ageing to amend the definition of Required Advisory Statements for Medicine Labels included in clause 2 'Interpretation' of Therapeutic Goods Order No. 69 General requirements for labels for medicines (TGO 69).

The TGA has commissioned an additional review of the information. Pending the outcome of this review, prescribers should include this potential additional risk in their consideration of appropriate drug therapy for Type 2 diabetes, taking into account that rosiglitazone should not be prescribed for patients with known ischaemic heart disease or those considered to be at high risk for ischaemic heart disease. Full document...

The United States Food and Drug Administration is hosting the 11th Global Harmonization Task Force (GHTF) Conference in Washington from the 3-4 October 2007. The GHTF is a forum of regulators and industry whose objective is to encourage convergence in regulatory practices related to ensuring the safety, effectiveness / performance and quality of medical devices. More info and Registration...

The TGA seeks input to assist in the development of Compositional Monographs for chelated and organic acid salt ingredients for use in low risk medicines under the proposed Australia New Zealand Therapeutic Products regulatory scheme. Full document...

This guidance tool is intended to be used to determine whether a product that falls within the 'grey-area' at the food-medicine interface would be regulated as a food or as a therapeutic product.

Termites (often incorrectly called 'white ants') feed on wood and serve an important function in nature by converting dead trees into organic matter. Unfortunately, the wood in buildings and other structures such as wooden power poles is equally appetising to termites, so they can cause serious damage which may be very expensive to repair. Full document...