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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 A new FDA draft guidance has been published outlining the requirements and implementation regarding valid electronic submission of MEIs.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
The FDA intends to publish a proposed rule that would replace current requirements for reports submitted on IND applications, according to an HHS inventory of agency rulemaking for 2017. Read More