Regulatory issues

FDA poised to start digital health pilot
FDA poised to start digital health pilot Forms a key part of the agency's new digital innovation action plan
European regulators mull use of… QR codes
European regulators mull use of… QR codes EMA’s Heads of Medicines Agencies committee outlines packaging proposals
FDA: Cybersecurity is an ever-present risk for medical devices
FDA: Cybersecurity is an ever-present risk for medical devices US regulator issues new guidance for manufacturers
Apps as medical devices - UK regulator updates its guidance
Apps as medical devices - UK regulator updates its guidance MHRA moves to help firms' health apps comply with its rules
UK patients offered app to report adverse reactions
UK patients offered app to report adverse reactions Yellow Card app allows potential side-effects tobe sent directly to the MHRA
FDA teams up with PatientsLikeMe for patient data project
FDA teams up with PatientsLikeMe for patient data project Will explore its potential to inform the regulator'approach to risk assessment
Google-backed genetic testing kit gains FDA approval
Google-backed genetic testing kit gains FDA approval 23andMe’s DNA test can alert consumers to their risks of certain diseases
The potential of regulated wearable technology
The potential of regulated wearable technology New health-tracking technologies are set to be taken seriously as medical devices
Guidance is no barrier to engaging on Twitter
Guidance is no barrier to engaging on Twitter Five simple, compliant tactics for European pharma marketers to consider
EMA expands adverse event reporting website
EMA expands adverse event reporting website Opens it up to all nationally-authorised medicines
Smartphone and social media adverse event project launched
Smartphone and social media adverse event project launched The EU consortium's members will include UK regulator the MHRA
PMCPA looks to app to simplify the APBI Code of Practice
PMCPA looks to app to simplify the APBI Code of Practice Code regulator takes 'digitally-led' approach in partnership with The Earthworks
Google: heavy regulation makes healthcare a painful business
Google: heavy regulation makes healthcare a painful business But Sergey Brin expects health to increase in importance for the search giant
FDA begins data initiative with millions of adverse event reports
FDA begins data initiative with millions of adverse event reports Will provide web developers and others with access to large public health datasets
New year, new attitudes in digital
New year, new attitudes in digital The real digital innovations in 2014 need to come in our attitudes, not our technologies
FDA releases draft social media guidance
FDA releases draft social media guidance Covers 'interactive promotional media', such as Facebook, Twitter and blogs
FDA takes 'tailored' approach to mobile app regulation
FDA takes 'tailored' approach to mobile app regulation Issues final guidance on smartphone and tablet computer technology
EMA prepares for digital signature introduction
EMA prepares for digital signature introduction From next month will accept digital signatures for certain procedures
Understanding the post-digital world
Understanding the post-digital world The ubiquity of digital demands that pharmaceutical companies focus more closely than ever on finding out what their customers want
Wanted: Social media innovation to detect AEs
Wanted: Social media innovation to detect AEs EU-pharma partnership seeks proposals on harnessing the power of the internet and social media to track adverse events

1 2 [ Next 20 results ]