Parenteral Drug Association
  

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PDA Technical Bulletins

PDA members have advocated the need for short position papers responding to issues raised during regulatory inspections around the world. Through its members, PDA develops scientifically based Technical Bulletins to address these issues. These documents can be used to support an industry response to a regulatory concern.

Topics for Technical Bulletins might also come from phone calls to PDA, PDA Interest Groups, and controversial topics raised on the PDA Pharmaceutical Sci-Tech Discussion Group. These focused documents address only a single issue in one to two pages and consist of an issue statement, recommendation, rationale for the recommendation and references, whenever available.

Following an limited expert review and brief comment period, finalized Technical Bulletins are reviewed and approved by the PDA Science Advisory Board (SAB), Biotechnology Advisory Board (BioAB) or the PDA Regulatory Affairs and Quality Committee (RAQC), as appropriate. Any substantive comments are incorporated into the report prior to publication. Technical Bulletins also require PDA Board of Director approval before publication.

Because of the importance of this information to scientific literature and research, Technical Bulletins are not only be stored on this Web site but are also be published in the PDA Journal of Pharmaceutical Science and Technology and the PDA Letter.

Latest Technical Bulletins (PDA Members Only)

 
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