Blog

EU Clinical Trial Regulation: What, When, Who, Why, How?

juin 15, 2021

The long-anticipated European Union (EU) Clinical Trial Regulation (Regulation (EU) No 536/2014) (CTR), intended to improve and coordinate the submission and review...

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Anticipating Obstacles to Approval Before Your Early Phase Oncology Study: Four Critical Areas to Consider

mars 25, 2021

The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have rigorous processes for reviewing applications for...

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EMA & FDA Approvals and Recommendations in 2020 for Oncology Drugs and Diagnostics/Devices

janvier 18, 2021

Similar to previous years, 2020 also proved overall to be a successful year for drug approvals despite the COVID-19 pandemic....

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Clinical Highlights from the First Virtual European Society for Medical Oncology Congress

décembre 11, 2020

This year’s ESMO Annual Scientific Meeting took place between 19th-21st of September, with the Educational Program occurring during the 16th-18th...

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Strategizing for NDA/BLA Series Part 2: Planning Ahead for Your NDA or BLA

décembre 9, 2020

This blog is the second part in our “Strategizing for NDA\BLA” series. The first part can be found HERE –...

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Current and Emerging Therapies for Patients With Multiple Myeloma

novembre 5, 2020

Multiple myeloma (MM) is a malignant disease of the bone marrow characterized by clonal expansion of plasma cells (1, 2)....

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Improving Informed Consent in Clinical Trials

octobre 16, 2020

Does more information mean better knowledge? Recruitment and retainment of patients for clinical trials can be a major challenge, especially...

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New FDA Guidance for October 2020 and Upcoming Advisory Committee Meetings

octobre 5, 2020

 Special Interest Guidances/Information Date Posted Providing Regulatory Submissions in Electronic Format — Standardized Study Data 29 October 2020 Nonclinical Testing...

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New FDA Guidances for August 2020 and Upcoming Advisory Committee Meetings

septembre 3, 2020

 Special Interest Guidances/Information Date Posted Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device...

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New FDA Guidances for July 2020 and Upcoming Advisory Committee Meetings

août 5, 2020

Special Interest Guidances/Information Date Posted Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended...

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