Standards & Regulations

Mar 23, 2018
By Pharmaceutical Technology Editors
The draft guidance addresses the agency’s policy on evaluating bulk drug substances in drug compounding.
Mar 23, 2018
By Pharmaceutical Technology Editors
The agency’s Committee for Medicinal Products for Human Use recommended six drugs for approval at its March 2018 meeting.
Mar 20, 2018
By Pharmaceutical Technology Editors
The agency published two new guidance documents detailing postmarketing safety reporting requirements for combination products.
Mar 20, 2018
By Pharmaceutical Technology Editors
The agency sent a warning letter to Malladi Drugs & Pharmaceuticals Limited after an inspection found CGMP violations that included the presence of vermin.
Mar 20, 2018
By Pharmaceutical Technology Editors
The agency’s Clinical Data Summary Pilot program will post redacted Clinical Study Reports in order to help stakeholders understand why FDA approved a new drug application.
Mar 16, 2018
By Pharmaceutical Technology Editors
The agency announced proposed research studies on how healthcare providers and patients understand drug promotional materials.
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.
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