Standards & Regulations

Aug 21, 2017
By BioPharm International 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 18, 2017
By BioPharm International Editors
The agency published guidance on identifying trading partners under DSCSA.
Aug 14, 2017
By BioPharm International 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 BioPharm International Editors
A pilot program will offer instruction on scientific and regulatory guidelines including training on GMPs and quality.
Aug 10, 2017
By BioPharm International 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.
Aug 08, 2017
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.
Aug 01, 2017
BioPharm International
FDA urges manufacturers to seek fast approval of “high-need” generics and targeted therapies. 
Aug 01, 2017
By BioPharm International Editors
The agency has developed a business continuity plan to ensure that the public’s health is protected during the agency’s relocation.
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