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cGMPs
Process Variability? FDA, Heal Thyself
Nov. 17, 2010
At the ISPE annual meeting in Orlando last week, FDA officials addressed the topic of training, and efforts to break down the walls separating the Agency's key functions.
Drug Approvals
FDA approves Italfarmaco Duchenne drug
March 22, 2024
Drug Approvals
Medicare to cover Wegovy for heart disease patients
March 22, 2024
Editors' (re)View
Editors' (re)View: J&J cast-off anti-hypertensive wins approval; Orchard prices MLD therapy at $4.25M
March 22, 2024
Aseptic Processing
Novo Nordisk invests $580M in China site expansion
March 21, 2024
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White paper: Enhancing virus clearance process capability using a biodegradable detergent
Key considerations for CGMP raw materials compliance
Intas hit with FDA warning letter
Beyond ‘good’ practices
Biocon hit with multiple 483s
Developing a cell and gene therapy packaging strategy
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