Regulatory/GMP Compliance

Nov 16, 2018
Moving forward with gene therapy development requires a “quantum leap” in manufacturing capabilities.
Nov 15, 2018
By BioPharm International Editors
The new good pharmacovigilance practice chapter IV on specific considerations for the pediatric population offers a holistic view of pediatric pharmacovigilance and provides guidance on how to address the specific needs and challenges of safety monitoring of medicines used in children.
Nov 14, 2018
Improving the manufacturing of gene therapy vectors will be crucial to making advanced treatments accessible to more patients who need them, agreed panelists at the 2018 Galien Forum.
Nov 14, 2018
By BioPharm International Editors
The agency sent a warning letter to the company for marketing an unapproved stem cell product and CGMP violations.
Nov 12, 2018
By BioPharm International Editors
The agency is developing a new way to assess, record, and report data from surveillance and preapproval inspections of sterile drugs.
Nov 09, 2018
By BioPharm International Editors
The new program will provide cell and gene therapy companies a more efficient way to ensure quality compliance across collection center networks and to minimize quality system audit burden on these centers.
Nov 08, 2018
By BioPharm International Editors
Permission from the United Kingdom's Supreme Court has been granted to the UK BioIndustry Association, allowing it to intervene in a dosage regimen patent case.
Nov 08, 2018
By BioPharm International Editors
Leaders of the two parties are open to challenging the status quo on drug costs and spending.
Nov 01, 2018
BioPharm International
Advanced therapy medicinal products pose unique manufacturing challenges that will require appropriate and thoughtful facility design and equipment.
Nov 01, 2018
BioPharm International
Industry is searching for ways to deal with the criticality of ensuring data integrity.
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