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August 23, 2017
FDA has signed a confidentiality commitment with the European Commission and the European Medicines Agency that allows FDA to share confidential information with EU regulations.
August 01, 2017
The agency is asking for comments on a reflection paper on developing drugs for the needs of older patients.
The agency has developed a business continuity plan to ensure that the public’s health is protected during the agency’s relocation.
July 28, 2017
The agency is asking public consultation on the concept paper.
July 21, 2017
The agency recommended a total of 11 drugs at its July meeting, including five orphan drugs.
July 10, 2017
The agency’s Pharmacovigilance Risk Assessment Committee made recommendations on the risk of multiple sclerosis treatments, injectable methylprednisolone medicines, and the use of gadolinium contrast agents.
July 05, 2017
ADV7103 is being evaluated in a Phase III trial in Europe in children and adults with distal renal tubulopathy acidosis. Results from the study are expected in the coming months.
June 28, 2017
The directorate highlights its 2016 achievements.
June 23, 2017
The agency recommended approval of treatments for hepatitis C, cancer, multiple sclerosis, and arthritis.
June 16, 2017
The agency’s management board discussed plans for the relocation of EMA at its June 2017 meeting.