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- PMLiVE

Drug approval trends

- PMLiVE

Centre for Innovation in Regulatory Science awarded $1.09m Gates Foundation grant

Grant will help accelerate medicine registration in low/middle-income countries

- PMLiVE

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

- PMLiVE

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

- PMLiVE

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

- PMLiVE

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

- PMLiVE

Google-backed genetic testing kit gains FDA approval

23andMe’s DNA test can alert consumers to their risks of certain diseases

- PMLiVE

Google-backed genetic testing kit gains FDA approval

23andMe’s DNA test can alert consumers to their risks of certain diseases

- PMLiVE

Astellas joins trial data sharing website

Joins Bayer, Boehringer, GSK, Lilly, Novartis, Roche and more

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