Survodutide advances metabolic disease treatment, while biosimilar capacity expands, FDA delays hemophilia review, and lupus data support next steps.
|Articles|September 15, 2002
- BioPharm International-09-01-2002
- Volume 15
- Issue 9
Reexamining the Set It and Forget It Approach
by Preston Poulter, Poulter Scientific, Inc. Process variations inevitably result in change, and change may mean new regulatory hoops. Statistical quality control is a cost-effective and efficient method for coping with change while still remaining compliant with 21 CFR Part 58.
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Articles in this issue
about 24 years ago
Security in the Corporate Homelandabout 24 years ago
Integrating New Technology into Blood Plasma Fractionationabout 24 years ago
Attack Mounts on Pharmaceutical Pricesabout 24 years ago
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Litifilimab extended skin responses through 52 weeks in phase 2 AMETHYST data in cutaneous lupus erythematosus, with phase 3 results expected in 2027.
Manufacturing remediation, not efficacy or safety data, is delaying US approval of Novo's h+emophilia A therapy denecimig.
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