Standards/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
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.
Aug 10, 2017
By Pharmaceutical Technology Editors
The China Food and Drug Administration has submitted its membership to the International Council for Harmonization.
Aug 10, 2017
Efforts to establish an international system for identifying and tracing drugs through the global supply chain are moving forward.
Aug 08, 2017
The Senate voted 94–1 to approve legislation reauthorizing user fees and a series of program changes; President Trump signs legislation.
Aug 02, 2017
Pharmaceutical Technology
The review of batch records creates a story of the materials, manufacturing, and packaging involved in the production of bio/pharmaceuticals, according to Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
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