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The FDA finalized its guidance for applicants on meeting regulatory requirements related to the content and formatting of the clinical pharmacology section of a proposed product label. Read More
The EMA has released guidance on the first steps it will take to prepare drug sponsors to comply with new data standards for the unique identification of drugs set to take effect in 2018. Read More
The House last night approved a new version of the 21st Century Cures bill after removing a provision on drug company payments to physicians that would have prevented its passage in the Senate. Read More