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February 25, 2019
A draft guidance document provides recommendations for submitting bioavailability information in investigational new drug and new drug applications.
February 22, 2019
The Pharmacovigilance Risk Assessment Committee of the European Medicines Agency has issued a recommendation for the suspension of fenspiride medicines across the whole of the European Union.
In a statement, FDA Commissioner Scott Gottlieb laid out the case for the safety and effectiveness of generic drugs compared to brand drugs.
February 21, 2019
The Swiss Agency for Therapeutic Products has begun entering GMP compliance information in the European Union’s EudraGMDP database.
As part of its support for novel nicotine replacement therapies, the agency published guidance on the development of these products.
February 20, 2019
The agency clarified the process for development programs for regenerative medicine therapies.
February 15, 2019
The two countries have been included in the mutual recognition agreement between the EU and US for GMP inspections.
A taskforce evaluated the advantage of using Big Data in the evaluation of the benefits versus risks of medications.
The guidance explains the process of applying for competitive generic therapy designation.
The drug is approved in the United States specifically for treating acquired thrombotic thrombocytopenic purpura, a rare blood-clotting disorder.