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The FDA has laid out a list of situations in which the agency would not enforce certain violations related to the compounding and repackaging of radiopharmaceuticals. Read More
Submissions of manufacturing establishment information (MEI) by manufacturers are about to be changed. A new FDA draft guidance has been published outlining the requirements and implementation regarding valid electronic submission of MEIs. Read More
Sanofi alleges Novo Nordisk engaged in a national advertising campaign that falsely claimed access to Sanofi’s diabetes therapies Lantus and Toujeo would be restricted next year. Read More
Aplicare landed an FDA warning letter after an inspection uncovered four significant GMP violations involving sterility controls and marketing claims for unapproved uses. Read More
The FDA updated its guidance for botanical drug development to include recommendations for navigating combination drug regulations, with possible criteria for receiving a waiver. Read More