Bioresearch Monitoring Program/IRB
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Generic medicine facts, questions and answers, and FDA review and approval process.Early Alert: Infusion Pump Issue from Baxter
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program“Jeni’s Splendid Ice Cream Voluntarily Recalls Passion Fruit Dreamsicle Ice Cream Bars Due to Undeclared Wheat and Soy.”
Jeni’s Splendid Ice Creams is voluntarily recalling one batch of Passion Fruit Dreamsicle Ice Cream Bars because they may contain undeclared wheat and soy. People who have an allergy or severe sensitivity to soy and/or wheat run the risk of serious or life-threatening allergic reactions if they consSafety Labeling Changes—Implementation of Section 505(o)(4) of the FD&C Act
This draft guidance provides information on the implementation of the statutory provision that authorizes FDA to require application holders for certain drug and biological products to make labeling changes based on new safety information that becomes available after approval of the drug.Fusion IV Pharmaceuticals Inc. dba Axia Pharmaceuticals, Los Angeles, CA. Amended 483 Issued 03/23/2017
Fusion IV Pharmaceuticals Inc. dba Axia Pharmaceuticals, Los Angeles, CA. Amended 483 Issued 03/23/2017Task Description Request Please post to the 2017 Pharmacy Inspections and Related Records Web page
Record Date 03/23/2017
FEI Number 3013341563
Firm Name Fusion IV Pharmaceuticals Inc. dba Axia PCompleted PDUFA VI Deliverables
Completed PDUFA VI Deliverables