Expedited development and review programs established by the US Food and Drug Administration (FDA) have a growing role in bringing drugs and biologics to market, with novel orphan and nonorphan ...

The US Food and Drug Administration (FDA) on Thursday issued a draft guidance to help manufacturers set up inspection testing programs to ensure that their injectable drugs are free of visible ...

FDA’s Center for Biologics Evaluation and Research (“CBER”) recently issued a trio of new draft guidances to assist sponsors who are developing and conducting postapproval studies of cell and gene ...

This chapter of this background paper describes the Food and Drug Administration’s (FDA) statutory authority and responsibility for new therapeutics, FDA programs begun as a result of legislative ...

Federal regulators are taking a coordinated step to accelerate the responsible integration of digital health technologies into routine care. Through the Centers for Medicare and Medicaid (CMS) ...

The Food and Drug Administration responded to a health policy group requesting clear enforcement of alternative funding programs, or AFPs. The agency reiterated its regulation against the foreign ...

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