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ClinicalTrials.gov received a new set of usability updates last month, including additional local search functions, a new glossary feature and redesigned study record pages. Read More
FDA released two guidance documents focusing on communications between the agency and drug developers to make drug development more efficient and to help sponsors avoid costly delays. Read More
Spending on prescription drugs sold through retail pharmacies in 2015 were estimated to comprise nearly 12 percent of total personal health care services spending in the United States. Read More
Closing what it calls an “unintended loophole,” the FDA will no longer issue orphan drug designations for smaller pediatric subpopulations of more common diseases, unless certain criteria are met. Read More
Makers of biopharmaceuticals will need to become more modular and agile to adjust for trends in personalized medicine and oncology, according to the Tufts Center for the Study of Drug Development. Read More
The European Medicines Agency adopted a guideline for sponsors developing new products for autism spectrum disorder, providing recommendations on diagnostic criteria, target populations and clinical trial design. Read More
The European Medicines Agency adopted the fifth revision of its substantive guideline covering all stages of oncology drug development, expanding upon the previous version’s section on safety data. Read More
The European Medicines Agency adopted the International Council for Harmonisation’s E17 guideline on multi-region clinical trials, which can support simultaneous product submissions in different parts of the world and more efficient drug development. Read More
CBER said it will prefer using internationally harmonized standards developed by third-party organizations — as opposed to maintaining its own — and it is urging sponsors of biologics to do the same, according to a new draft guidance. Read More
The FDA published guidance assisting sponsors in evaluating the effects of psychoactive drugs on the ability to operate a motor vehicle. The agency recommends a tiered approach to evaluating drug effects, consisting of pharmacology/toxicology, epidemiology and clinical behavioral assessments. Data obtained early in development can be used to guide the collection of subsequent data related to driving impairment, for a better allocation of sponsor resources. Read More