Quality Systems

Jun 20, 2018
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Regulatory authorities have published draft guidance on strategies to facilitate pharmaceutical lifecycle management.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 BioPharm International 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 BioPharm International 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 BioPharm International 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.
Jun 04, 2018
By BioPharm International Editors
The company is recalling two lots of Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL, Carpuject Single-use cartridge syringe system due to particulate matter on the syringe plunger.
Jun 04, 2018
By BioPharm International Editors
EMA has recommended marketing authorization for Aimovig (erenumab), a new treatment for migraine.
Jun 04, 2018
By BioPharm International Editors
The FDA commissioner announced proposed steps to modernize the organization and functions of CDER’s Office of New Drugs.
Jun 01, 2018
BioPharm International
Higher cell titers and cell densities have posed a challenge to cell harvesting, a crucial step in biologics manufacturing.
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