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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.
January 11, 2018
The European Commission has approved AstraZeneca’s benralizumab, a monoclonal antibody for treating severe asthma.
January 10, 2018
Will Alex Azar’s experience in the pharmaceutical industry help or hurt the initiative to keep medications affordable?
January 05, 2018
FDA Commissioner Gottlieb expects that the saline and amino acid drug shortages from Puerto Rican manufacturing facilities will improve in the early part of 2018.
FDA noted in a recent inspection that American CryoStem was receiving and processing adipose tissue into a product called Atcell, and then marketing the product without agency approval.
In a roundtable Q&A with biopharma executives, the vulnerability and challenges of dealing with extractables and leachables in single-use bioreactor bags are explored.
January 04, 2018
The company is voluntarily recalling product because of glass particles found in vials.
January 03, 2018
The agency published draft guidance on good practices for submitting abbreviated new drug applications.
January 02, 2018
PharMEDium Services, LLC voluntarily recalled some lots of product because of a lack of sterility assurance.
The repercussions of EMA’s relocation and Brexit will continue to be the dominant regulatory issue throughout 2018.
FDA looks to achieve near-record level of new drug approvals following slowdown in 2016.