Nephron Pharmaceuticals Corporation
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Latest From Nephron Pharmaceuticals Corporation
The Quality Lowdown: US FDA Warning Letters, 483 Reports Hit Poor Sterility And Lax Investigations
Bristol-Myers Squibb’s Abraxis Unit, Nephron and Lupin hit with warning letters; Lupin and Jubilant 483 inspection reports posted.
US FDA Once Again Dings Rx Drug Sponsored Link For Excluding Risk Information
Eton Pharmaceuticals gets untitled letter for promotion of its Alkindi Sprinkle hydrocortisone granules for treatment of pediatric adrenal insufficiency. The agency sent two letters last year objecting to sponsored links after a decade pause.
US FDA Actions On Rx Drug Promos Covered New Territory Last Year
Office of Prescription Drug Promotion issued just six letters citing companies for improper drug promotion in 2020, including the placement of safety information in an email and making unfounded COVID-19 claims. New research projects focus on celebrity endorsements, medical conference materials.
Azurity’s Xatmep Promotional Email To Healthcare Professionals Gets Dinged By US FDA
In second letter this year targeting email communications, OPDP says that putting the methotrexate oral solution’s risk information below the signature block does not offer ‘prominence and readability’ comparable to the information on the drug’s effectiveness for the treatment of acute lymphoblastic leukemia that was in the body of the email.
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