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September 14, 2016
FDA sent a warning letter to an Illinois compounding pharmacy for violations of the Federal Food, Drug, and Cosmetic Act.
The agency provides a qualified context of use for the biomarker plasma fibrinogen.
September 07, 2016
Regulatory agencies meet to discuss approaches to the development of antibacterial agents.
September 02, 2016
Manufacturers and regulatory authorities seek coordinated lifecycle management policies.
The media blitz surrounding drug shortages has stopped, but critical medications that have no substitutes remain in short supply. Can new approaches turn this situation around?
September 01, 2016
FDA cites two Xinxiang Tuoxin Biochemical facilities with CGMP deviations.
August 31, 2016
Sandoz won FDA approval for its biosimilar version of Enbrel.
August 29, 2016
The Parenteral Drug Association develops program to address barriers to implementation of postapproval changes.
The guidance assists in the development, analysis, and presentation of microbiology data during antibacterial drug development.
FDA issued a warning letter to College Pharmacy for multiple violations.