Standards/Regulations

Apr 02, 2018
Pharmaceutical Technology
The flexibility and incompatibility of ICH Q12 guidelines with current EU legislations raise complications.
Apr 02, 2018
Pharmaceutical Technology
Implementing electronic batch records can offer a means of compliance, reduction in errors, streamlined ability to trace actions, and simultaneous generation of documentation.
Apr 02, 2018
Pharmaceutical Technology
Certificates of analysis can be used to monitor the reliability of products and their suppliers, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
Mar 29, 2018
Congress passed a $1.3-trillion omnibus budget bill March 22, 2018 that increases federal support for biomedical research and health programs for fiscal year 2018.
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The draft guidance addresses the agency’s policy on evaluating bulk drug substances in drug compounding.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.
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