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Drug sponsors are eager for the FDA to embrace real-world evidence, but several companies are asking the agency to clarify how it can be used in clinical trials. Read More
Congressional Democrats are calling on the FDA to answer “substantive questions” surrounding the agency’s approval of Dsuvia, AcelRx’s sublingual formulation of the powerful opioid sufentanil. Read More
The agency will issue a letter to ANDA applicants informing them of the requirement to establish a shared REMS with the sponsor of the referenced NDA. Read More
The lack of a standard definition for drug shortages in the EU is preventing regulators from developing an EU-wide strategy for handling shortages, according to the European Medicines Agency. Read More