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Posted 23 April 2012 | By Alexander Gaffney, RAC
Australia's Therapeutic Goods Administration (TGA) announced 23 April it is looking for comments on its draft guideline outlining the types of evidence needed to support indications made for low-risk medicines.
TGA's guideline,Evidence Required to Support Indications for Listed Medicines (excluding sunscreens and disinfectants), is intended to replace an earlier guideline entitled, Guidelines for Levels and Kinds of Evidence to Support Indications and Claims for Non-Registerable Medicines, including Complementary Medicines and other Listable Medicines.
TGA said in a statement it "intends to embed the document within the legislative framework for regulation of therapeutic goods in Australia," and that the document's recommendations have already been "agreed to in principle" when they were released in the report TGA Reforms: A blueprint for TGA's future.
The guideline's key features include:
TGA - Consultation document on levels and kinds of evidence to support indications and claims for listed medicines - feedback invited
TGA - Evidence required to support indications for Listed medicines (excluding sunscreens and disinfectants) - draft
Tags: Indication, Latest News, pharmaceutical, claims, label, australia, safety, drug
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This article provides a variety of websites with important information on recent changes to FDA guidances and tables ...