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The FDA rejected two citizen petitions urging the agency to allow biosimilar sponsors to use the same nonproprietary names as their reference products, finding them incompatible with final guidance on the agency’s naming scheme published earlier this month. Read More
Pressed for details by a Senate committee Tuesday, Rep. Tom Price (R-Ga.) — President Donald Trump’s pick to lead HHS — refused to confirm whether or not he would push for the power to negotiate Medicare drug prices, but said he was open to ideas. Read More
The European Medicines Agency said 30 drugs across four therapeutic classes have received conditional marketing authorization in the EU since the expedited approval pathway became available a decade ago. Read More
On the administration’s first full workday yesterday, President Donald Trump froze federal hiring for most agencies, leaving the FDA with about 500 job vacancies out of its workforce of 15,000. Read More
The International Council on Harmonization is proposing to expand guidance concerning data quality, medication errors and product issues by developing a more detailed companion document that would include Q&A sections and more examples. Read More
The World Trade Organization ratified an amendment to the Trade Related Aspects of Intellectual Property Rights (TRIP) agreement, authorizing developing countries with limited production capacity to import generics when facing a drug shortage. Read More