Quality Systems

Jun 22, 2018
By Pharmaceutical Technology Editors
The approval is intended to increase patient access to treatment for opioid addiction.
Jun 22, 2018
By Pharmaceutical Technology Editors
The agency published guidance about requests for Prescription Drug User Fee Act waivers, refunds, and reductions in user fees.
Jun 21, 2018
By Pharmaceutical Technology Editors
The contract development and manufacturing company has received an additional approval from Health Canada to manufacture monoclonal antibody drug substance at its first plant in Icheon, South Korea.
Jun 20, 2018
Pharmaceutical Technology
Legislators have requested that FDA do more to prevent drug shortages.
Jun 08, 2018
Regulatory authorities have published draft guidance on strategies to facilitate pharmaceutical lifecycle management.
Jun 07, 2018
By Pharmaceutical Technology Editors
The company will provide the first FlexFactory manufacturing platform for TCR T-cell therapy manufacturing.
Jun 07, 2018
The agency is encouraging team-based reviews and streamlined processes that will make the oversight process more efficient and consistent.
Jun 06, 2018
By Pharmaceutical Technology Editors
The International Society of Pharmaceutical Engineering (ISPE) is field-testing the design principles of a comprehensive, industry-led program of self-evaluation of pharmaceutical quality that will align with the purpose of FDA’s quality metrics.
Jun 04, 2018
By Pharmaceutical Technology Editors
EMA has recommended marketing authorization for Aimovig (erenumab), a new treatment for migraine.
Jun 04, 2018
By Pharmaceutical Technology Editors
The agency has recommended approval of three biosimilar adalimumab products from Novartis, referencing AbbVie’s Humira, and a biosimilar trastuzumab from Pfizer, referencing Roche’s Herceptin.
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