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Two Endo International subsidiaries sued the FDA last week to have the agency’s bulk drug compounding decree on compounding operations declared illegal and to halt compounding involving the API vasopressin. Read More
The European Medicines Agency’s pharmacovigilance committee recommended additional restrictions on Biogen’s Zinbryta (daclizumab), after reviewing its effects on the liver. Read More
The FDA published a draft guidance explaining the new GDUFA fee structure and the types of fees that took effect Oct. 1. The draft also covers how to submit payments to the agency, the consequences for failing to pay, and how to request reconsiderations of user fee assessments. Read More
An EU regulation meant to boost pediatric drug development has led to more medicines for children since it was adopted, although actual use of new products has not increased at the same pace, a European Commission report said. Read More