Drug approval trends
Centre for Innovation in Regulatory Science awarded $1.09m Gates Foundation grant
Grant will help accelerate medicine registration in low/middle-income countries
Will biosimilars ever catch on in the US?
Why biosimilars are viewed in the US as ‘me too’ drugs rather than as just-as-good alternatives to branded products
The changing nature of approvals – what does the future hold?
The 2019 CMR International Pharmaceutical R&D Factbook
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
EMA’s Heads of Medicines Agencies committee outlines packaging proposals
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
MHRA moves to help firms' health apps comply with its rules
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
Will explore its potential to inform the regulator'approach to risk assessment
Google-backed genetic testing kit gains FDA approval
23andMe’s DNA test can alert consumers to their risks of certain diseases
Google-backed genetic testing kit gains FDA approval
23andMe’s DNA test can alert consumers to their risks of certain diseases
Astellas joins trial data sharing website
Joins Bayer, Boehringer, GSK, Lilly, Novartis, Roche and more