Standards/Regulations

Oct 05, 2017
FDA and manufacturers strive to prevent drug shortages from Hurricane Maria.
Oct 01, 2017
BioPharm International
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 01, 2017
BioPharm International
Industry and FDA face new fee structures and new challenges in implementing fee initiatives.
Sep 28, 2017
By BioPharm International Editors
The agency will require training for healthcare providers who prescribe immediate-release opioids.
Sep 28, 2017
By BioPharm International Editors
The draft guidance gives recommendations for reproductive toxicity testing and labeling.
Sep 28, 2017
By BioPharm International 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 25, 2017
By BioPharm International Editors
FDA participated in a global operation to combat the sale and distribution of unapproved and illegal drugs.
Sep 25, 2017
Biopharmaceutical companies developing new competitive biotech therapies have pressed hard for clarity on the testing and data required by FDA to gain market approval of biosimilars that can be filled by a pharmacist without prescriber preapproval.
Sep 21, 2017
By BioPharm International Editors
The agency sent out 13 warning letters on Sept. 19, 2017 to companies selling drug products online.
Sep 19, 2017
By BioPharm International Editors
Validation and batch testing failures were among the violations found by the FDA at the company’s Jiangsu facility.
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