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The FDA rejected Vanda Pharmaceuticals petition to delay the approval of ANDAs referencing its schizophrenia therapy Fanapt until its three-year market exclusivity for a new indication expires. Read More
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