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The EMA is clarifying agency expectations on the implementation of risk-based models and exposure limits to prevent cross-contamination during manufacturing in a Q&A guideline, telling manufacturers that all products should have health-based exposure limits (HBEL). Read More
Advanced therapy medical products are facing several development hurdles, ranging from inadequate regulatory guidance to insufficient funding, the EMA said. Read More
The FDA will no longer redact the CVs of its advisory committee members, in response to a Freedom of Information Act lawsuit filed by Public Citizen last year. Read More
The Office of Management and Budget on Friday clarified President Trump’s new “one in, two out” regulations order, narrowing its scope to significant regulations with an economic impact of over $100 million per year — and said the release of new guidance documents would be considered on a case-by-case basis. Read More
The European Medicines Agency for the first time published data on its clinical data website from a withdrawn application, while adding clinical study reports for two generics. Read More
Japan’s largest drugmaker, Takeda Pharmaceuticals, said it will maintain its existing pricing model in the U.S., despite President Donald Trump’s call for drug companies to lower their prices. Read More
The European Parliament’s committee on Environment, Public Health and Food Safety voted Tuesday to approve a draft report that includes dozens of recommendations for improving how the EU promotes access to medicine and handles safety, intellectual property, and pricing issues. Read More