Topline phase 3 data show epcoritamab plus R-CHOP reduced the risk of progression or death by 51% in newly diagnosed diffuse large B-cell lymphoma.
|Articles|October 15, 2002
- BioPharm International-10-01-2002
- Volume 15
- Issue 10
Preparing Biological Product Deviation Reports: Suggestions for Manufacturers
Author(s)Barbara Unger
by Barbara W. Unger, Don Hill Associates, Inc. Rarely do manufacturers of biologics need to prepare a Biological Product Deviation Report (formerly called and Error and Accident Report); in fact, few manufacturers ever have to complete one. But all manufacturers need to have an SOP describing how to complete this report, in case it becomes necessary.
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FDA Launches Major CGMP Reviewalmost 24 years ago
Process Validation: How Much to Do and When to Do Italmost 24 years ago
Biotech Will Recover!almost 24 years ago
GMPs and Pharmaceutical Labelingalmost 24 years ago
Revolutionizing Biologics RegulationAdvertisement
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