d) Each new OD application must have a Research Product Identifier (RPI) – the process for requesting an RPI will be required before OD application. About orphan drug designation The European Medicines Agency (EMA) plays a central role in facilitating the development and authorization of medicines...
New drug applicationDrug approvalDrug lagReview periodSubmissionThe Korean regulatory authority has enacted legislation to expedite the new drug approval (NDA) process. However, the effectiveness of such efforts in reducing review time and drug approval delays between Korea and the USA/EU remains to ...
89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today announce...
The EMA was in the process of reviewing the vaccine for emergency authorization and is expected to make a ruling later this month. Pfizer and BioNTech’s mRNA vaccine, BNT162b2 demonstrated a 95% efficacy in clinical trials. The U.S. Food and Drug Administration will review the clinical ...
the approval process of biosimilar medicines contains some unique and specific considerations. This review aims to address the regulatory framework of biosimilar medicines, their development process and the approval requirements by the European Medicines Agency (EMA) and the Food and Drug Administration (...