FDA uncovers data manipulation at Immunomedics plant making cancer drug

FDA uncovers data manipulation at Immunomedics plant making cancer drug

Submitted by admin on February 14, 2019 - 10:02am
Source: 
Fierce Pharma
News Tags: 
FDS
Immunomedics
sacituzumab govitecan
drug manufacturing
Headline: 
FDA uncovers data manipulation at Immunomedics plant making cancer drug
snippet: 

The FDA has released a Form 483 from the inspection of the Immunomedics plant showing big issues with data integrity at the Morris Plains, New Jersey, plant where sacituzumab govitecan is being made.

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