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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.
March 07, 2019
Janssen’s Spravato (esketamine) gains approval with restricted distribution guidelines.
March 06, 2019
Gottlieb’s tenure included record new drug approvals and steps taken to curb opioid abuse.
March 05, 2019
The FDA commissioner plans to leave the agency in April.
March 04, 2019
FDA guidance on quality considerations for continuous manufacturing should help advance implementation by providing clarity and giving companies more confidence to make investments in the new technology.
The company is voluntarily recalling four lots of Drospirenone and Ethinyl Estradiol Tablets, USP because of the possibility they may contain defective blister packs and incorrect tablet arrangements.
March 02, 2019
Do patients get what they pay for when they demand cheaper drugs?
Understanding the API, delivery mechanism, and excipient functionality is essential to solving drug solubility challenges.
Simplification is crucial to maintain data integrity, according to Siegfried Schmitt, PhD, vice-president, technical at PAREXEL Consulting.
FDA expects more than 200 investigational new drug applications for cell and gene therapies by 2020, causing the agency to strengthen its regulatory program.
February 25, 2019
A draft guidance document provides recommendations for submitting bioavailability information in investigational new drug and new drug applications.