Bethesda, Md., March 2, 2017 – The Parenteral Drug Association (PDA) today announced the availability of two “PDA Papers” authored by the Post-Approval Changes for Innovation in Availability of Medicines (PAC iAM) Task Force in the “Accepted Articles” section of the PDA Journal of Pharmaceutical Science and Technology (PDA Journal).
The papers, “PDA Points to Consider: Technical Product Lifecycle Management: Communication and Knowledge Exchange between Marketing Authorization Holders and Health Authorities” and “PDA Points to Consider: Technical Product Lifecycle Management Pharmaceutical Quality System Effectiveness For Managing Post-Approval Changes”, are “open access” manuscripts. The two papers are part of an extensive work plan by the PAC iAM Task Force that was announced on September 19, 2016.
The Task Force is conducting a survey and has begun work on a PDA Technical Report. The group will meet at the upcoming PDA Annual Meeting in April.
“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 “publish-ahead-of-press”, and are fully citable. PDA launched this capability in 2016.