Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.

Changes include the new definition of “Broad Spectrum” UVA, based on a test which is more stringent than current; and for SPF, a modified test method. Read about these changes in Dermatest’s newsletter. (Source: Dermatest)

Compositional guidelines for “added alpha-casozepine enriched hydrolysed milk protein”, “DHA-rich oil derived from microalgae Schizochytrium sp.”, “Steviol glycosides” and “Zeaxanthin” have been added to the TGA website. (Source: TGA)

The product names are Capadex, Di-Gesic, Doloxene and Paradex. These products will be cancelled from the Australian Register of Therapeutic Goods on 1st March 2012. The TGA believes that the risks (serious adverse cardiovascular events) outweigh the benefits. (Source: TGA)

Topics include GMP audits, clinical trials, release of therapeutic goods for supply in Australia, and quality risk management. (Source: http://www.tga.gov.au/newsroom/events-presentations-manuf.htm)

Peter Foster was arrested on November 11th and placed into custody over the SensaSlim nasal spray, which was marketed with false claims. Foster has been convicted previously over Bai Lin slimming tea, the Chaste Corporation, financial crimes in the Pacific island countries, and was controversially an adviser to Cherie Blair, the wife of then British PM Tony Blair. (Source: ACCC)

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