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Latest From Research & Development
Public session to gather input on taxonomy and scientific criteria for qualifying animal models, biomarkers and clinical outcome assessments is early step toward satisfying 21st Century Cures Act requirements and PDUFA VI commitments.
Independent assessment finds positive perceptions of expanded access program but calls on agency to do more to correct manufacturer misperceptions about adverse events and clarify when data from expanded access would support labeling extensions.
Developing advanced therapy medicinal products is not easy, but the head of regulatory affairs at Swedish cell therapy company Immunicum has some useful tips for SMEs that could help them navigate their development more easily.
The drug value assessment organization said it is considering whether or not to move forward with a program to consult pharmaceutical manufacturers on early research, a move that could raise questions about the group's independence.
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