Newsletter - July 23, 2015
EMA to Follow FDA-Like Practice to Advice on Post-Marketing Study Design
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 design of these studies and requires mandatory reporting of the results. However, in Europe, post-authorization safety studies (PASS) could be either mandatory, or voluntary. Read More...
FDA Wants to Know Drug Side-Effects by Google Search
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. This led several pundits to claim that FDA is forming an alliance with Google to use the search engine giant’s resources to capture better pharmacovigilance information. Read More...
FDA Rapidly Updating its Policies to Regulate Medical Software to Match the Technological Realities
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 for CDS software applications as medical devices become increasingly connected to digital interfaces such as mobile platforms and the Internet of Things (IoT) where they exist in an ecosystem of data, software and other physical devices. Read More...
EMA to Follow FDA-Like Practice to Advice on Post-Marketing Study Design
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 design of these studies and requires mandatory reporting of the results. However, in Europe, post-authorization safety studies (PASS) could be either mandatory, or voluntary. Read More...
FDA Wants to Know Drug Side-Effects by Google Search
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. This led several pundits to claim that FDA is forming an alliance with Google to use the search engine giant’s resources to capture better pharmacovigilance information. Read More...
FDA Rapidly Updating its Policies to Regulate Medical Software to Match the Technological Realities
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 for CDS software applications as medical devices become increasingly connected to digital interfaces such as mobile platforms and the Internet of Things (IoT) where they exist in an ecosystem of data, software and other physical devices. Read More...