Standards/Regulations

Oct 11, 2017
By Pharmaceutical Technology Editors
Europe updates the guideline on excipients information in labeling and packaging.
Oct 11, 2017
By Pharmaceutical Technology Editors
The agency published guidance on developing antiviral drugs to treat respiratory syncytial virus infection.
Oct 05, 2017
By Pharmaceutical Technology Editors
Both regulatory bodies are working on enhancements to their respective adverse event reporting systems in efforts to increase transparency and safety monitoring of drugs.
Oct 05, 2017
FDA and manufacturers strive to prevent drug shortages from Hurricane Maria.
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.
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