Top 10 Under 40
Up-and-Coming Stars Shine in Biopharma Research and Business
Podcast: FDA’s New Commissioner Hits the Ground Running
Scott Gottlieb, M.D., Commits to Speeding Up Drug Reviews, and Maintaining Safety and Efficacy
Liquid Biopsies Remain Wait and See for Some Clinicians
Circulating Biomarker Assays Promise to Refresh Cancer Profiling and Monitoring Practices
Biomarker Validation for Genomic Assays
Assay Developers Put Their Tests to the Test and Demonstrate the Clinical Utility of Genomic Biomarkers
For full access to this article login to GEN Select now.
FDA Backs PAT to Help Solve Manufacturing Woes
Process Analytical Technology Is a Key Part of Agency’s Plan for the 21st Century
- Process analytical technology (PAT) has been the subject of regular discussion since the FDA released its guidance for the industry in September 2004. The goal, then and now, was to provide a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement and control of critical variables ...
Not registered yet? Please fill out the form below and enjoy complimentary access to this and an exclusive collection of premium content and personalization features as a GEN Select insider. Learn More.
Get GEN Select Access Now
- Do not put any letters or characters here if you are not a spy program.