Product safety is one of the key themes in our latest edition of OTC.NewDirections, with two stories related to supplements in Australia. The country’s medicines agency, TGA (Therapeutic Goods Administration), has announced a review of oxedrine (synephrine) and caffeine, both of which are ingredients commonly found in energy and weight loss supplements. The issue of caffeine’s safety has become a hot topic for regulators across the world, notably in the US, where the FDA has been reviewing 1,600 AERs (Adverse Event Reports) for caffeine-based foods and supplements.
Now two years since the FDA issued its draft guidance on the regulation of mobile medical apps, the agency has now published its long-awaited final guidance. Marketers will be relieved that the FDA has said it will only focus on the small proportion of apps that function like medical devices, such as those that turn smartphones into blood glucose monitors or electrocardiography machines, rather than all healthcare apps. Innovators in the field will appreciate the clarity that this guidance brings and the fact that the FDA will not require clinical trials for new apps that resemble medical devices already on the market.
In the latest edition of OTC.NewDirections, we reveal more on this story and provide a round-up of various other developments affecting medical devices over the past fortnight. These include new EU measures on medical devices in the wake of the breast implant scandal that broke in 2010, as well as an FDA ruling on unique device identification (UDI) systems and the agency’s effort to boost development of medical devices for children by awarding various grants.
Our latest edition also features expert commentary from our partners JensonR+ on a wide range of topics from restrictions on analgesics in Denmark, to homeopathy claims in the UK and classification changes for glucosamine in Finland. For more on these stories, and the latest scientific findings on supplements, make sure you subscribe to the bulletin.