GMPs

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
The agency published guidance on developing antiviral drugs to treat respiratory syncytial virus infection.
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.
Sep 28, 2017
By Pharmaceutical Technology Editors
The draft guidance gives recommendations for reproductive toxicity testing and labeling.
Sep 27, 2017
By Pharmaceutical Technology Editors
The FDA commissioner made a statement about the agency’s efforts to ensure patient access to safe compounded medicines.
Sep 25, 2017
Pharmaceutical companies should prepare for the impact of recalls to minimize risk to consumers and the company.
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