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Data updated through July 2024Safety 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This draft guidance provides information on the implementation of the statutory provision that authorizes FDA to require application holders for certain drug and biological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. 483, Second Amended 483 Issued 03/23/2017
Task 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 Pharmaceutical
Record Type 483
State CA
Establishment Type Producer of Sterile Drug ProductsDrug Development Tool Qualification Process: Transparency Provisions
Under the 21st Century Cures Act enacted on December 13, 2016, the new section 507 Qualification of Drug Development Tools was added to the Federal Food, Drug, and Cosmetic Act and formally establishes an updated, multi-stage process for DDT qualification. This process includes three submission milNational Drug Code Directory
National Drug Code DirectoryCANCELED – 17th Annual Sentinel Initiative Public Workshop – 11/06/2025
The U.S. Food and Drug Administration, under a cooperative agreement with the Duke-Margolis Institute for Health Policy, is hosting the 16th Annual Sentinel Initiative Public Workshop on November 6, 2025