Standards/Regulations

Apr 20, 2018
By Pharmaceutical Technology Editors
A federal judge from the Eastern District of Arkansas entered into a consent decree with Cantrell Drug Company.
Apr 19, 2018
By Pharmaceutical Technology Editors
The new document answers questions regarding implementation of the ICH Q7 guidance on GMPs for APIs.
Apr 18, 2018
By Pharmaceutical Technology Editors
The European Pharmacopoeia Commission has approved a general monograph laying down harmonized requirements for LBPs for human use and two general chapters addressing microbiological contamination of LBPs.
Apr 16, 2018
By Pharmaceutical Technology Editors
A new report gives an overview of the work of the International API Inspection Program.
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.
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