Drug Research and Review Issues on Radar at FDA

It will be a challenge for FDA to match or exceed its success this past year in approving record numbers of innovative and generic drugs. These achievements reflect the ability of biopharma companies to capitalize on important advances in science, as well as strong support from the regulators in Powered by WPeMatico Continue reading Drug Research and Review Issues on Radar at FDA

Identity Crisis: Data Protection Roles for Life Sciences Companies

James Clark The advent of the General Data Protection Regulation (GDPR) has brought with it a complicated range of challenges for businesses operating in life sciences. From transparency and privacy notices, to the use of consent, from contracts with service providers, to extended data Powered by WPeMatico Continue reading Identity Crisis: Data Protection Roles for Life Sciences Companies

5 Ways to Shape a Regulatory Affairs Workforce for the Future

Karin Van Baelen With the ever-changing healthcare landscape, I encourage my Global Regulatory Affairs (GRA) team at Janssen R&D to be nimble, curious and forward-thinking in everything they do. Why? Because with more than 30 years spent in pharmaceutical R&D and regulatory, I a Powered by WPeMatico Continue reading 5 Ways to Shape a Regulatory Affairs Workforce for the Future

Experts Probe Economic Factors Driving Drug Shortages

Patients, providers and policy makers are up in arms over persistent and more prevalent shortages of important medicines, primarily generic sterile injectables needed to treat critical diseases and infections, provide emergency care, and enable surgery and multiple aspects of medical care. Despi Powered by WPeMatico Continue reading Experts Probe Economic Factors Driving Drug Shortages