Standards & Regulations

Apr 11, 2018
By Pharmaceutical Technology Editors
The agency has assigned new EU member state rapporteurs and co-rapporteurs to medicines previously assigned to the UK’s Medicines and Healthcare products Regulatory Agency.
Apr 11, 2018
By Pharmaceutical Technology Editors
FDA sent a warning letter to Tris Pharma Inc. after investigators found the company had failed to properly investigate batch failures and establish quality control procedures.
Apr 06, 2018
By Pharmaceutical Technology Editors
The European Pharmacopoeia Commission added 19 new monographs and three new chapters and revised 51 monographs and 15 chapters.
Apr 05, 2018
By Pharmaceutical Technology Editors
The agency’s plan outlines its approach to implementing medical product programs and the use of financial resources.
Apr 03, 2018
By Pharmaceutical Technology Editors
The agency has release a report providing an overview of steps taken to enhance benefit-risk assessment in the review of drugs.
Apr 03, 2018
By Pharmaceutical Technology Editors
The company is recalling Pasta De Lassar Andromaco zinc oxide diaper rash treatment after FDA analysis confirmed the product contained high levels of yeast, mold, and bacteria.
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.
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