Standards & Regulations

Nov 01, 2017
BioPharm International
Reliable, high-quality products require innovative analytics and production.
Oct 31, 2017
By BioPharm International Editors
A mutual recognition agreement to accept inspection data from eight EU regulatory authorities may reduce inspection burdens at global drug facilities.
Oct 25, 2017
By BioPharm International Editors
FDA sent a warning letter to Ridge Properties, LLC, after inspectors found a variety of current good manufacturing practice violations at the company’s Salem, OR facility.
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.
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