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The European Medicines Agency issued a draft paper to clarify the responsibilities of marketing authorization holders (MAHs) under the EU’s GMP regulations, which the EMA conceded can be confusing. Read More
The Institute for Clinical and Economic Review (ICER) has updated its drug value assessment process for 2020 to include more real-world evidence, a one-year reevaluation and other new elements. Read More
The Trump administration last week unveiled a pilot Medicaid program that would allow participating states to negotiate drug prices by choosing the drugs covered for certain adults under age 65 — an approach that PhRMA strongly opposes. Read More
Drugmakers are ramping up efforts to develop countermeasures for the coronavirus outbreak, which the World Health Organization yesterday declared a global health emergency. Read More