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.