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April 19, 2024
At INTERPHEX 2024, Wenyu Zhang, PhD, covered new trends in the aseptic industry and the key factors companies should consider while weighing their options.
April 17, 2024
ADC manufacturing facilities are requiring more stringent containment requirements as well as advanced analytical detection.
At INTERPHEX 2024, Susan Schniepp, distinguished fellow, Regulatory Compliance Associates, and co-chair of board of directors, Parenteral Drug Association, explores the impact of QMS on quality maturity.
Former FDA drug investigator, Daniel Roberts, discusses the importance of updating process validation and maintaining proper data integrity at a keynote session during INTERPHEX.
March 16, 2024
FDA published the draft guidance to support sponsors in developing treatments for the states of sporadic Alzheimer’s disease.
March 11, 2024
The Alliance will receive the NSF Regional Innovation Engines Development Award and $1 million in funding.
March 08, 2024
The Data Analysis and Real World Interrogation Network, DARWIN EU, is planning to add 10 new data partners in 2024.
March 07, 2024
The agency has published final guidance documents regarding validation and development of analytical procedures.
March 04, 2024
Accurately targeted immunotherapies through reliable neoantigen recognition enable personalized medicine development.
February 28, 2024
Steffen Thirstrup, chief medical officer, EMA, emphasizes the importance of transparency in investigating potential safety issues of CAR-T therapies, while highlighting the need to balance regulatory diligence with maintaining trust within the community and among stakeholders.