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© 2020 MJH Life Sciences and BioPharm International. All rights reserved.
© 2020 MJH Life Sciences™ and BioPharm International. All rights reserved.
October 15, 2020
Connect with pharmaceutical and healthcare regulatory authorities around the world via this directory.
October 05, 2020
The agency sent an open letter to European Ombudsman Emily O’Reilly affirming the agency’s intention to apply the same standards to the evaluation of COVID-19 treatments as it does to other medicines.
October 02, 2020
Automation, digitalization, and supply-chain strategies help mitigate vulnerabilities in both autologous and allogeneic cell therapy manufacturing.
October 01, 2020
Fill/finish inspection for vaccine vials and syringes must remain GMP-compliant while aiming for fast, efficient methods.
Best practices to consider when transitioning from research-grade to GMP-grade materials.
Drug shortages and supply chain challenges bolster FDA efforts to promote modern manufacturing.
September 25, 2020
Telstar has reinforced its consultancy service to aid pharmaceutical companies in the compliance of the latest version of the EU GMP Annex 1 guidance.
September 22, 2020
ISPE has released new guidance on the cleaning validation lifecycle, written by a group of experts and reviewed by regulators and practitioners.
September 21, 2020
Fears about overly accelerated development programs has heightened demands for wider access to information on study protocols, statistical analysis plans, and early results.
September 17, 2020
The guidance document offers information on the placement and content of geriatric information in labeling of drugs and biologics.