Blog

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

December 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

December 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

November 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

October 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

October 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

September 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

August 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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Immuno-oncology updates in the virtual era – ASCO 2020

July 27, 2020

This year’s ASCO Annual Scientific Meeting took place between May 29-31, with the Education Program planned for August 8-10. Unlike previous...

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New FDA Guidances for June 2020 and Upcoming Advisory Committee Meetings

July 5, 2020

 Special Interest Guidances/Information Date Posted Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry – Final Guidance 30...

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Are you ready for the new European clinical trial regulation?

June 29, 2020

The new European Clinical Trial Regulation (ECTR) will replace the 2001/20/EC Directive, the directive that currently describes how clinical trials should be conducted in...

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