OR WAIT null SECS
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.
November 02, 2018
This paper describes how the concept of acceptance value can be redefined to remove bias and more closely reflect quality targets.
Survey results and record attendance show positive signs for various bio/pharma regions.
Experts share best practices, and war stories, for a crucial but often underappreciated part of drug development.
New FDA guidance offers a time buffer but increases supply-chain-management complexity, as active DSCSA enforcement begins.
October 31, 2018
A statement from FDA Commissioner Scott Gottlieb and Deputy Commissioner Anna Abram detailed FDA’s new plan to advance plant and animal biotechnology innovation.
Mock inspections-if conducted properly-can prepare a pharma company for the day FDA knocks on the door.
October 30, 2018
The companies announced the European launch of Imraldi (adalimumab), a biosimilar referencing AbbVie’s blockbuster Humira (adalimumab).
Mylan announced the launch of its biosimilar to AbbVie’s Humira across major European markets.
October 26, 2018
A new proposal aims to reduce reimbursement for medicines administered to seniors under the Part B benefit to an amount pegged to the average price paid in foreign industrial nations.
October 24, 2018
The agency has approved Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza.