GMPs

Feb 15, 2018
By Pharmaceutical Technology Editors
FDA Commissioner Scott Gottlieb issued a statement that FDA will be modernizing regulatory programs in order to advance novel treatments.
Feb 14, 2018
By Pharmaceutical Technology Editors
The agency provides information on the appropriate regulatory classification of pharmaceutical co-crystal solid-state forms.
Feb 07, 2018
By Pharmaceutical Technology Editors
The guidance addresses the development, analysis, and presentation of microbiology data during antibacterial drug development.
Feb 02, 2018
Pharmaceutical Technology
Drug manufacturers can improve use of quality agreements in contract manufacturing.
Feb 02, 2018
Pharmaceutical Technology
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 02, 2018
Pharmaceutical Technology
Greater clarity and harmonization in ATMP regulations are needed to promote the development and commercialization of these therapies.
Feb 02, 2018
Pharmaceutical Technology
This article explores lab data integrity violation trends, as well as a sampling of the latest technologies that can help avoid them.
Feb 02, 2018
Pharmaceutical Technology
Steve Hayward, product marketing manager at BIOVIA, Dassault Systèmes, discusses the importance of both technology and people in the modern laboratory.
Feb 01, 2018
Pharmaceutical Technology
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
Pharmaceutical Technology's In the Lab eNewsletter
By Pharmaceutical Technology Editors
Federal agencies have partnered to develop a roadmap that offers a new framework for the safety testing of drugs and chemicals without the use of animals.
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