The US Food and Drug Administration has implemented a full complement of coronavirus containment measures, including travel and meeting restrictions, that might endanger user fee goals and by extension product approvals.
US FDA Freezes Inspections And Outside Meetings. Will Review Goal Dates Stay Put?
Sponsors have been asked to switch to teleconferences with FDA staff as the agency prepares for more of its employees to work from home.
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Newly published insights from a series of European Medicines Agency workshops can guide drug developers in designing development plans that meet the needs of both regulators and health technology assessment bodies.
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The weight management drug, Mysimba, continues to demonstrate a positive benefit-risk balance but the data available are not sufficient to fully determine the cardiovascular safety beyond 12 months. Meanwhile, Currax this month announced the publication of a peer-reviewed study of Mysimba that followed patients for over 4.7 years and found no evidence of excess cardiovascular risk.
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This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
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