Argent BioPharma has started formal clinical supply of its EU-GMP cannabinoid-based active pharmaceutical ingredient (API) ...

The FDA has issued its much-anticipated final guidance on cybersecurity risk management in medical devices, effective June ...

Best practices are to follow ALCOA+ principles, as well as FDA's 21 CFR Part 11 and EU GMP Annex 11. These regulations and guidelines treat the accuracy of data recorded, legibility, real-time ...