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September 24, 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 18, 2020
The guidance document offers information on the placement and content of geriatric information in labeling of drugs and biologics.
The agency sent a warning letter to Kalchem International for CGMP violations found at the company’s Lindsay, OK, facility.
September 15, 2020
GenSight Biologics has submitted a marketing authorization application to the European Medicines Agency for Lumevoq.
September 14, 2020
The temporary guidance discusses the resumption of normal manufacturing during the COVID-19 pandemic.
September 09, 2020
Imfinzi has been granted approval in the EU for the treatment of adults with extensive-stage small cell lung cancer.
September 02, 2020
Despite pharmacovigilance legislation being in place for nearly a decade, many companies are still struggling to fulfill obligations.
The 2020–2025 EMRN strategy will be regularly reviewed over the coming five years to accommodate science and technology advances.