FDA

Clinical trials for new medicines

The Australian Life Scientist has an article on the top 10 mistakes made in setting up and running the clinical trials for TGA and FDA legal and regulatory approvals:

Special feature: Top 10 clinical trial mistakes

by James Cameron of McCullough Robertson.

Lid dip: Kim O’Connell at Mallesons.

Domain names and regulatory requirements

If the (US) FDA requires you to include information about the risks of using your drug and Google’s AdSense has a 95 character limit, what do you do?

Prof. Manara explores how companies, particularly pharmaceutical companies, are using domain names to ensure that their online presence doesn’t contravene regulatory requirements such as FDA requirements to include information about risks in materials advertising drugs.

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