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It is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.
Validating computerized systems is required to demonstrate adherence to data integrity, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.
Quality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. ecosystem.
October 13, 2017
The committee has voted unanimously to approve Spark Therapeutics’ gene therapy candidate, Luxturna (voretigene neparvovec), for treating a genetically inherited blindness.
October 11, 2017
Amgen is seeking approval for an additional indication in glucocorticoid-induced osteoporosis for its blockbuster osteoporosis therapeutic, Prolia.
AstraZeneca is seeking approval for its anti-cancer monoclonal antibody, Imfinzi, for treating non-small cell lung cancer in the European Union.
The agency published guidance on developing antiviral drugs to treat respiratory syncytial virus infection.
Europe updates the guideline on excipients information in labeling and packaging.
The guidance gives recommendations for resolving scientific or regulatory issues with FDA regarding ANDA applications.
FDA published guidance on the format and content of REMS documents.
October 05, 2017
FDA and manufacturers strive to prevent drug shortages from Hurricane Maria.
Both regulatory bodies are working on enhancements to their respective adverse event reporting systems in efforts to increase transparency and safety monitoring of drugs.
October 02, 2017
The agency published four guidance documents regarding ANDAs and amendments to ANDAs.