FDA is planning to publish a guidance document on “clinical decision support” (CDS) software, i.e., software that interfaces patient data and clinical decision making, by the end of this year. There is intense speculation about what FDA’s approach to regulate CDS software may be. In this month’s edition of Nature Biotechnology, Elenko et al. examined the emerging regulatory framework … Read more
Last month FDA officials met Google experts and the web was buzzing with speculation about the context of the discussion. Both FDA and Google have kept mum about the topic of discussion but one of the Google attendees is an expert in data mining and has published articles on using web searches by people to link side-effects to drugs. … Read more
Since 2011, FDA has required many sponsors of newly approved drugs to conduct mandatory post-marketing safety studies. These studies could be required as a post-marketing commitment before a drug can be approved or if a new safety concern is raised after the product becomes available in the US market. FDA also advises the manufacturers about the … Read more
