US FDA invites biologics sponsors to participate in electronic submission pilot
This article was originally published in SRA
The US Food and Drug Administration is inviting biologic drug makers to participate in a pilot programme to test the value of using its new electronic data standard format to submit non-clinical study data related to investigational new drug applications1.
You may also be interested in...
Tezepelumab was among four products that the European Medicines Agency most recently considered for review under its accelerated assessment mechanism.
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include five new products, including Lumoxiti, AstraZeneca's drug for hairy cell leukemia. The list, which contains information dating back to January 2018, comprises brand name, generic name, company, therapeutic indication, date of marketing authorization announcement and product type (eg, medicine, vaccine, biologic).
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 European Union, and updates on EU marketing authorization changes recommended by the CHMP.