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PAC iAM Papers Available on PDA Journal Website

by Walter Morris, PDA | Apr 04, 2017

Two “PDA Papers” authored by members of PDA’s Post-Approval Changes for Innovation in Availability of Medicines (PAC iAM) Task Force are now available in the “Accepted Articles” section of the PDA Journal of Pharmaceutical Science and Technology.

The papers, “PDA Points to Consider:Technical Product Lifecycle Management:Communication and KnowledgeExchange between Marketing AuthorizationHolders and Health Authorities” and “PDA Points to Consider: TechnicalProduct Lifecycle Management PharmaceuticalQuality System Effectiveness forManaging Post-Approval Changes,” are open access manuscripts available to both PDA members and nonmembers. The two papers are part of an extensive workplan by the task force to address the need for improved post-approval change processes within the industry.

The task force is currently conducting a survey and has begun work on a PDA technical report. In addition, there will be a workshop on post-approval changes Sept. 13–14, following the 2017 PDA/ FDA Joint Regulatory Conference.

“PDA Papers” are special contributions to the PDA Journal and represent the official viewpoint of PDA. The “Accepted Articles” section of the PDA Journal is for articles that have been accepted for publication but have yet to appear in an official edition, commonly referred to as “published-ahead- of-press,” and are fully citable. PDA launched this capability in 2016.