Standards & Regulations

Aug 28, 2017
High-priority issues requiring immediate attention leave little time for Congress to consider drug access proposals that have limited bipartisan support.
Aug 24, 2017
By Pharmaceutical Technology Editors
The US Pharmacopeial Convention is hosting a variety of workshops in Autumn 2017 on a wide range of topics including continuing education, bioassays, and peptides.
Aug 23, 2017
By Pharmaceutical Technology Editors
FDA sent a warning letter to Bicooya Cosmetics Limited after inspectors found rodent feces at the company’s Zhejiang, China facility.
Aug 23, 2017
By Pharmaceutical Technology Editors
FDA has signed a confidentiality commitment with the European Commission and the European Medicines Agency that allows FDA to share confidential information with EU regulations.
Aug 21, 2017
By Pharmaceutical Technology Editors
The directors of FDA’s Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health praised Congress’ reauthorization of user fee programs.
Aug 21, 2017
By Pharmaceutical Technology Editors
A meeting of the Pediatric Advisory Committee will advise on the use of prescription opioid medications containing hydrocodone or codeine in children’s cough medicine.
Aug 18, 2017
By Pharmaceutical Technology Editors
FDA sent a warning letter to Maple Rose Enterprises, Inc., dba Pencol Compounding Pharmacy, citing the company for violations of sterile manufacturing practices.
Aug 18, 2017
PTSM: Pharmaceutical Technology Sourcing and Management
By Pharmaceutical Technology Editors
The agency published guidance on identifying trading partners under DSCSA.
Aug 14, 2017
By Pharmaceutical Technology Editors
The agency sent a warning letter to Cellex-C International regarding GMP violations found at the company’s Toronto facility.
Aug 14, 2017
By Pharmaceutical Technology Editors
A pilot program will offer instruction on scientific and regulatory guidelines including training on GMPs and quality.
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