Quality Systems

Feb 07, 2018
By BioPharm International Editors
The guidance addresses the development, analysis, and presentation of microbiology data during antibacterial drug development.
Feb 07, 2018
By BioPharm International Editors
The agency met to discuss its new temporary and permanent premises in Amsterdam.
Feb 06, 2018
By BioPharm International Editors
Paratek has completed submission of two new drug applications for oral and intravenous omadacycline, a new antibiotic for pneumonia and skin infections.
Feb 02, 2018
By BioPharm International Editors
The NECC supervisory pharmacist at the center of the 2012 fungal meningitis outbreak was sentenced to 8 years in prison.
Feb 01, 2018
BioPharm International
CRLs put the brakes on drug development and damage corporate reputation and stock prices. Upfront investment and better sponsor oversight are ways to prevent them.
Feb 01, 2018
BioPharm International
The approaches for sample preparation of preclinical evaluation of safety and efficacy are addressed taking into consideration the shortcoming with the contemporary approaches.
Feb 01, 2018
BioPharm International
Regardless of the phase of development and the level of GMPs being applied, there should be adequate controls and knowledge to assure patient safety, according to Susan Schniepp, fellow at Regulatory Compliance Associates.
Feb 01, 2018
BioPharm International
Manufacturers tackle regulatory and competitive issues to develop complex therapies and biosimilars.
Feb 01, 2018
BioPharm International
Frustrated with high costs and drug shortages, hospitals adopt a DIY approach.
Feb 01, 2018
BioPharm International
As closure integrity testing moves from a probabilistic to a deterministic basis, designs are promoting improved control and reduced operator contact.
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