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The European Medicines Agency wants to develop a common data model (CDM) to help speed Europe’s drug development and it’s looking for a hybrid because no current system can answer all the questions posed by the product life cycle. Read More
The FDA issued draft guidance that outlines what the agency considers an ideal and robust verification system that’s also in line with legislative requirements. Read More
International regulators need to take action to reverse the steep decline in research and development for antibiotics, according to the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). Read More
Piggybacking on a petition from Pfizer, Novartis called on the FDA to debunk common myths about biosimilars and better educate consumers about their safety and efficacy. Read More
FDA Commissioner Scott Gottlieb said the agency is committed to ensuring “timely completion” of post-marketing studies by drug sponsors in a Friday statement about the agency’s latest report on the status of reviews. Read More
The agency is considering assessing the orphan designation at the marketing authorization stage to encourage applications for rare disease treatments. Read More
CMS approved Michigan’s plan to allow its Medicaid program to negotiate “value-based” payment arrangements with drugmakers, linking drug costs to patient outcomes such as quality of life improvements, CMS Administrator Seema Verma announced Wednesday. Read More
The agency said the EU will monitor developments in the field to ensure that the regulatory framework supports —and not hinders — the development of ATMPs. Read More