The US FDA released guidance titled "Referencing Approved Drug Products in ANDA Submissions" to help generic medication companies deal with these potential issues. The agency aims to dispel any confusion induced by the usage of RLD and reference standard (RS) and to provide particular guidance when referring to the mentioned items in a generic ANDA application. With our Clinical Trial Sourcing services, Ikris Pharma Network assists biopharmaceutical research and development activities on a global scale. It specializes in the acquisition and distribution of pharmaceuticals, associated clinical supplies, and active pharmaceutical ingredients for clinical trials and drug development projects and is a trusted and recognised RLD supplier. For more details visit https://www.ikrispharmainternational.com/rldsourcing.php |
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