The FDA approves Inluriyo-Verzenio combo for ESR1-mutated breast cancer; EMBER-3 data double PFS, with supply chain and diagnostics implications for manufacturers.
News|Articles|May 25, 2012
Scientific Programme Officer — Pharmaceutical Care and Anti-Counterfeiting Programme (Grade A1/A2)
The EDQM (European Directorate for the Quality of Medicines and HealthCare) are looking to recruit a Scientific Programme Officer to join the team for a five year period to organise, manage and monitor a number of projects related to Pharmaceutical Care and Anti-Counterfeiting activities with a particular focus on the implementation of the MEDICRIME Convention
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This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory Conference, and Hovione expanded its spray drying capacity.
Andrea K. Kerrigan, FDA, outlines how validation, data integrity, and QRM determine whether digital tools and AI strengthen or undermine CGMP compliance.
PDA/FDA 2026 session maps the GMP audit lifecycle, root cause to CAPA closure, plus a local vs. above-site decision framework and two case studies.
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This article explores the historical use of silicone oil in the performance of primary drug product packaging; design of experiment test results for selection of the cleaning agent and CCPs; assessment of visible residue limits and Fourier-transform infrared spectroscopy surface analysis; and setting health-based exposure limits for silicone oil using a non-uniform distribution model, and a previously published permitted daily exposure.
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