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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
CDER Director Janet Woodcock announced on Tuesday that Sally Chloe will be the new director of the Office of Generic Drugs at the end of the month. Read More
A joint FDA advisory committee voted in favor of the safety, efficacy and risk-benefit profile of Janssen’s NDA for treatment of treatment-resistant depression. Read More