FDA issues new guidance on e-CTD specifications

Jan 3, 2013. FDA issued a draft (out for comment) revision to their Guidance “Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Certain Human Pharmaceutical Product Applications and Related Submissions Using the Electronic Common Technical Document Specification”. Continue reading

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Regxia at DIA Europe in March – Booth 834

Regxia is excited to announce our second showing at the DIA Annual Euromeeting in Amsterdam, The Netherlands March 4-6! We hope you are able to visit us at Booth 834 while we are there! Continue reading

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Health Canada plans to launch a Canadian Clinical Trials Registry

Health Canada plans to launch a Canadian Clinical Trials Registry

Dec 13, 2012. Health Canada has plans to pursue the development of mandatory requirements for the registration and disclosure of clinical trials and study results. In the interim, Health Canada intends to provide access to its internal clinical trial database. Health Canada’s clinical trial database is generally updated by about 800 clinical trials per year, for the study of drugs in patients. Continue reading

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