Standards/Regulations

Oct 23, 2017
By Pharmaceutical Technology Editors
EDQM held a symposium on microbiology to gather industry feedback on alternative testing methods for microbiological control and sterilization processes.
Oct 20, 2017
By Pharmaceutical Technology Editors
The European Commission and EMA have created an action plan to address challenges identified by stakeholders involved in developing advanced therapies.
Oct 11, 2017
By Pharmaceutical Technology Editors
FDA published guidance on the format and content of REMS documents.
Oct 11, 2017
By Pharmaceutical Technology Editors
The guidance gives recommendations for resolving scientific or regulatory issues with FDA regarding ANDA applications.
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
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.
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