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The new US Food and Drug Administration (FDA) guidance will…
The new US Food and Drug Administration (FDA) guidance will enhance credibility of AI models in drug and biological product regulatory submissions.
FDA’s new draft guidance follows the new requirement for clinical…
FDA’s new draft guidance follows the new requirement for clinical study sponsors to submit Diversity Action Plans, eg, when submitting their investigational new drug (IND) application.
In this article, EPR’s Hannah Balfour discusses the recent multi-country…
In this article, EPR’s Hannah Balfour discusses the recent multi-country monkeypox outbreak, highlighting key developments in the international response.
The new clinical trial guidance asks sponsors to submit a…
The new clinical trial guidance asks sponsors to submit a Race and Ethnicity Diversity Plan outlining how they plan to enrol participants from underrepresented populations.
The FDA has requested a 2023 budget of $8.4 billion…
The FDA has requested a 2023 budget of $8.4 billion from the US Government, a $2.1 billion increase in funding from 2022.
New non-profit organization to speed pharmaceutical R&D...
19 September 2012 | By Bristol-Myers Squibb
New non-profit organization to speed pharmaceutical R&D...
First project will be to develop and implement protocol for…
28 February 2012 | By Bristol-Myers Squibb Company
First project will be to develop and implement protocol for Phase II study in IPF...
