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The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a revised guideline on the clinical investigation of medicines for the treatment of Alzheimer’s disease, focusing on the design and analysis of safety studies and the potential use of biomarkers in various stages of medicinal development. Read More
The FDA released guidance on the International Council for Harmonization’s good clinical practice guidelines and its addendum on advances in clinical trial design. Read More
In its first ever annual report, the Office of Pharmaceutical Quality highlighted its main accomplishments in 2017 and noted it faced major challenges with more than 100 of its 1,300 officers deployed for inspections in the aftermaths of Hurricanes Harvey, Irma and Maria. Read More
Commenting on FDA’s planned patient-focused drug development guidance, industry stakeholders said the agency needs to clarify how it will incorporate patient experience data into specific stages of development. Read More
Additionally, 21 member states impose penalties for falsification across the manufacturing supply chain, including manufacturing, distribution, brokering, import, export and sale at a distance. Read More