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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.
April 02, 2023
A further setback to the publication of the pharmaceutical legislative changes in Europe may mean time is running out for appropriate review before 2024 parliamentary elections.
March 31, 2023
FDA has approved Evkeeza for young children with homozygous familial hypercholesterolemia.
March 30, 2023
Takeda received approval in Japan for a subcutaneous injection formulation of Entyvio (vedolizumab) for treating ulcerative colitis.
Pierre Luzeau, CEO of Seqens, discusses Seqen's commitment to sustainability and how one can work toward it within their own company.
The Supreme Court heard oral arguments concerning the legitimacy of “genus clauses” in bio/pharma patents.
March 29, 2023
Narcan, from Emergent Solutions, will be the first naloxone product permitted for use without prescription by FDA.
March 24, 2023
A new Interagency Working Group for Bayh-Dole will review the government’s authority to revoke licenses for medical products.
March 20, 2023
How confident are you in your lab results? This paper explores this question and, by way of a worked example, provides a methodology to answer it.
March 16, 2023
27 drugs within Medicare will face penalties for having their prices raised faster than the rate of inflation.
March 15, 2023
Technological advances hold promise for mitigating human error in the pharmaceutical industry, especially in quality assurance/quality control, by reducing the incidence of, and risk associated with, mistakes.