Standards/Regulations

Oct 11, 2017
By BioPharm International Editors
FDA published guidance on the format and content of REMS documents.
Oct 11, 2017
By BioPharm International Editors
The guidance gives recommendations for resolving scientific or regulatory issues with FDA regarding ANDA applications.
Oct 11, 2017
By BioPharm International Editors
The agency published guidance on developing antiviral drugs to treat respiratory syncytial virus infection.
Oct 11, 2017
By BioPharm International Editors
Europe updates the guideline on excipients information in labeling and packaging.
Oct 05, 2017
By BioPharm International 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 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The draft guidance gives recommendations for reproductive toxicity testing and labeling.
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