Standards/Regulations

Apr 24, 2018
By Pharmaceutical Technology Editors
EMA and its new host country have finalized the terms of the agency’s relocation to Amsterdam.
Apr 20, 2018
By Pharmaceutical Technology Editors
FDA’s Center for Drug Evaluation and Research has published its second annual report on key safety programs and activities.
Apr 20, 2018
By Pharmaceutical Technology Editors
The agency has released new guidance on the development of new medication-assisted treatments for opioid dependence.
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.
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