Jun 02, 2018
Pharmaceutical Technology
By minding knowledge gaps, bio/pharma companies can avoid development pitfalls.
Jun 02, 2018
Pharmaceutical Technology
Open communication channels between all the parties involved is key when outsourcing analytical methods, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
May 07, 2018
Smaller review divisions will bring experts closer to decision processes and reduce bottlenecks, FDA leaders say.
May 02, 2018
Pharmaceutical Technology
Monetary benefits will outweigh the hassle of batch record harmonization, says Siegfried Schmitt, principal consultant at PAREXEL.
Mar 14, 2018
A previously published article presented difficulties with the revised European guidelines on sterile manufacturing. The authors included a brief summary of the comments developed on the draft document. This article expands upon that summary, outlines the authors' rationale, and highlights the most difficult aspects of the revision draft.
Mar 02, 2018
Pharmaceutical Technology
FDA enforcement efforts and drug approvals trend upward.
Feb 02, 2018
Pharmaceutical Technology
Hospitals form not-for-profit drug company to combat drug shortages and high prices.
Jan 24, 2018
Viewpoint: The revised Annex 1 on sterile manufacturing includes incorrect and ambiguous statements that must be fixed before implementation.
Jan 02, 2018
Pharmaceutical Technology
Bio/pharma professionals manage expectations amid industry uncertainty.
Dec 02, 2017
Pharmaceutical Technology
Is pharma up to the task of developing knowledgeable, motivated employees?
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