Standards/Regulations

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 13, 2018
By Pharmaceutical Technology Editors
Revisions to chapters on glass containers and elastomeric closures were canceled following review of comments.
Mar 08, 2018
The FDA commissioner outlined the agency's initiatives to reward innovation and biosimilars development.
Mar 02, 2018
Pharmaceutical Technology
In-house experts can help select the right systems and suppliers, making validation and compliance easy, says Siegfried Schmitt, principal consultant at PAREXEL.
Mar 02, 2018
Pharmaceutical Technology
Manufacturers face demands for timely information on clinical studies, product recalls, and approvals.
Mar 02, 2018
Pharmaceutical Technology
The upcoming serialization deadline and the United Kingdom's departure from the European Union could result in supply bottlenecks.
Feb 23, 2018
By Pharmaceutical Technology Editors
The agency clarifies recommendations found in ICH Q11 about chemical entities and biotechnology entities.
Feb 21, 2018
By Pharmaceutical Technology Editors
Divinity Products Distribution of Grain Valley has voluntarily agreed to destroy and recall kratom-containing dietary supplements as part of FDA's crackdown on the plant.
Feb 21, 2018
By Pharmaceutical Technology Editors
The agency released draft guidance on the format for electronic submissions of NDA and BLA content regarding the planning of bioresearch monitoring inspections.
Feb 15, 2018
By Pharmaceutical Technology Editors
The agency has approved a new treatment for a certain type of prostate cancer using novel clinical trial endpoint.
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