Standards/Regulations

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.
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
PTSM: Pharmaceutical Technology Sourcing and Management
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 04, 2017
By Pharmaceutical Technology Editors
Following passage by the House in July 2017, the Senate has voted to pass a reauthorization bill for FDA user-fee programs for drugs and medical devices ahead of the user-fee programs’ expiration date.
Aug 02, 2017
Pharmaceutical Technology
FDA’s Emerging Technologies Team (ETT) team chair Sau Lee describes the reasons for the team and its structure.
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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