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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
| 27 February 2012 | By Alexander Gaffney, RAC
The US Food and Drug Administration (FDA) released a new training tool to the public on 24 February for international regulators to "learn first-hand how [the Center for Drug Evaluation and Research (CDER)] organizes the drug review process and carries out its mission of ensuring the safety and efficacy of human drug products in the US."
The tool, CDER World, acts as an Internet-based "compendium of information" about how CDER operates as an agency, adapts to the legislative process and works to advance regulatory science.
Three online courses are currently available for download: compliance, generic drug regulation and new drug regulation.
FDA notes that new courses will be added periodically.
FDA - CDER World: Making the Work of CDER Transparent on the Web
Tags: New Drugs, CDER World, Latest News, regulatory science, pharmaceutical, international, information, training