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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2).” The question and answer (Q&A) format is intended to inform prospective applicants and facili.
The 2020 symposium will provide regulatory perspectives on the importance of sponsor oversight of clinical sites and laboratories, eSource including electronic health records, protocol deviations including the impact on clinical trials and the challenges in ensuring data quality in novel clinical tr.
Novel drugs (2015): A report on the more innovative products approved by FDA. These products often help advance clinical care to another level. Each year, FDA approves hundreds of new medications, most of which are variations of previously existing products, such as important new dosage forms of already-approved products, or cost-saving generic formulations. These new products contribute to quality of care, greater access to medication, more consumer choice, and a competitive marketplace that enhances affordability and public health.

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