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It is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.
Validating computerized systems is required to demonstrate adherence to data integrity, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.
Quality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. ecosystem.
February 15, 2018
FDA Commissioner Scott Gottlieb issued a statement that FDA will be modernizing regulatory programs in order to advance novel treatments.
February 14, 2018
The Trump budget boosts funding for FDA but squeezes resources for NIH and healthcare.
The agency provides information on the appropriate regulatory classification of pharmaceutical co-crystal solid-state forms.
February 12, 2018
FDA sent a warning letter to Celltrion detailing CGMP violations, including poor microbial contamination control.
February 08, 2018
Gottlieb promoted the development of biosimilars and safer opioid packaging at a briefing sponsored by Alliance for a Stronger FDA and the Pew Charitable Trusts.
February 07, 2018
The guidance addresses the development, analysis, and presentation of microbiology data during antibacterial drug development.
The agency met to discuss its new temporary and permanent premises in Amsterdam.
February 06, 2018
Paratek has completed submission of two new drug applications for oral and intravenous omadacycline, a new antibiotic for pneumonia and skin infections.
February 02, 2018
The following study describes a methodology to establish, control, and characterize an aerosolized bioburden within a test chamber and determine the settling rate of the bioburden.
Steve Hayward, product marketing manager at BIOVIA, Dassault Systèmes, discusses the importance of both technology and people in the modern laboratory.