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Showing posts with label PDA. Show all posts
Showing posts with label PDA. Show all posts

Thursday, February 9, 2017

PDA Position Paper: A Call For Reform In Global Post-Approval Change Processes





By the PDA Post Approval Change: 
Innovation for Availability of Medicines (PAC iAMSM) Task Force*


The seamless delivery of high quality, effective, and safe medicines to patients is each drug company’s ultimate duty. However, providing medication to patients is by no means effortless, as evidenced by the drug product shortage listings on health authority websites. The availability of medicines is challenged by a variety of factors, one of which is global supply chain segmentation due to global regulatory hurdles imposed on product related post-approval changes (PACs).

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