Quality Systems

Oct 01, 2018
FDA is joining with other federal health agencies and the biomedical research community to advance the science, regulatory policies, and reimbursement strategies to support innovation in antimicrobials.
Sep 28, 2018
By BioPharm International Editors
The agency sent a warning letter to the Indian company after an inspection found CGMP violations that included a lack of written procedures and analytical testing.
Sep 27, 2018
By BioPharm International Editors
The agency has entered into an agreement with the National Academies of Science, Engineering & Medicine and has expanded agreements with the University of Maryland and Johns Hopkins University Centers for Regulatory Science and Innovation to conduct research on the compounding of drugs.
Sep 27, 2018
By BioPharm International Editors
The agency announced that differences in strength expression on product labels of compounders and conventional manufacturers may lead to dosing errors.
Sep 20, 2018
By BioPharm International Editors
The agency will review Praluent (alirocumab) Injection, a PCSK9 inhibitor, as a possible treatment of cardiovascular events.
Sep 14, 2018
By BioPharm International Editors
FDA testing has found an additional impurity, N-Nitrosodiethylamine, in the API valsartan.
Sep 12, 2018
BioPharm International
FDA is revising its inspection process and seeks harmonization of standards for US and foreign regulatory oversight to ensure the safety of medicines.
Sep 10, 2018
By BioPharm International Editors
Gore’s new flexible freeze containers are designed to protect high-value drug substances from container breakage or leakage.
Sep 10, 2018
FDA, innovator companies, and biosimilar developers maneuver over exclusivity, naming, interchangeability, and more.
Sep 04, 2018
By BioPharm International Editors
As it investigates the root cause of an impurity discovered in valsartan, FDA extends its studies to APIs with similar synthesis processes.
native1_300x100
lorem ipsum