Standards & Regulations

Oct 02, 2017
Pharmaceutical Technology
Just as FDA strengthens ties between reviewers and plant inspectors, proactive manufacturers are involving different disciplines in preparation for FDA audits.
Oct 02, 2017
Pharmaceutical Technology
Focusing on whether the product meets its defined quality attributes should help one make reasonable, documentable, and defendable risk-based decisions, according to Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
Oct 02, 2017
Pharmaceutical Technology
Industry and FDA face new fee structures and new challenges in implementing fee initiatives.
Oct 02, 2017
By Pharmaceutical Technology Editors
The agency published four guidance documents regarding ANDAs and amendments to ANDAs.
Sep 28, 2017
By Pharmaceutical Technology Editors
The agency will require training for healthcare providers who prescribe immediate-release opioids.
Sep 28, 2017
By Pharmaceutical Technology Editors
FDA sent a warning letter to Shandong Vianor Biotech Co., Ltd. that claimed the company failed to follow proper data integrity and quality control procedures.
Sep 28, 2017
By Pharmaceutical Technology Editors
The draft guidance gives recommendations for reproductive toxicity testing and labeling.
Sep 27, 2017
By Pharmaceutical Technology Editors
The FDA commissioner made a statement about the agency’s efforts to ensure patient access to safe compounded medicines.
Sep 26, 2017
By Pharmaceutical Technology Editors
Staff survey on the relocation of EMA indicates that the future of public health in Europe is at stake.
Sep 25, 2017
PTSM: Pharmaceutical Technology Sourcing and Management
By Pharmaceutical Technology Editors
FDA participated in a global operation to combat the sale and distribution of unapproved and illegal drugs.
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