Drug Discovery World

JULY 25, 2023

These guidelines facilitate open communication between regulators and researchers, enabling the industry to adapt and conduct more robust and efficient paediatric clinical studies, while avoiding unnecessary trials. The section on ethics covers two examples of paediatric ethical factors to consider.

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Alta Sciences

DECEMBER 14, 2023

Adherence to harmonized pharmacy-specific SOPs based on cGMP principles at our three clinical pharmacology units. Exceptional inspection results from major regulators such as the FDA, HC, EMA, and MHRA. Regulatory Excellence - Licenses for Schedule I through IV drug substances.

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Agency IQ

FEBRUARY 2, 2024

What We Expect the FDA to do in February and March 2024 (Updated) In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

MARCH 1, 2024

What We Expect the FDA to do in March and April 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. Read AgencyIQ’s analysis of a lower court’s ruling.

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Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Alta Sciences

JULY 31, 2024

Regulatory organizations like Health Canada, the International Council for Harmonisation (ICH), and the European Medicines Agency (EMA) have long emphasized the importance of including diverse populations in clinical research. Discover how drug developers, researchers, and regulators are ensuring this happens.

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The Anticancer Fund

JUNE 7, 2022

Clinical investigation of this approach, particularly with respect to the sequencing of chemotherapy and immunotherapy, is warranted. Gauthier Bouche & Pan Pantziarka Gauthier Bouche (MD) is Director of Clinical Research at the Anticancer Fund. You can easily subscribe to this newsletter by clicking here.

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