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.
August 16, 2016
The agency publishes guidance on the appropriate classification of co-crystal solid-state forms.
The company received breakthrough therapy designation for esketamine, a treatment for major depressive disorder with imminent risk for suicide.
August 15, 2016
The agency has adopted guidelines on the pharmacovigilance of biological drugs.
August 11, 2016
NICE recommends secukinumab for the treatment of patients with ankylosing spondylitis.
The agency released the GMP guidance to help manufacturers ensure accurate data and minimize risk.
August 10, 2016
FDA issued a warning letter to contract testing laboratory, Adamson Analytical Laboratories, for CGMP violations.
August 09, 2016
The company is voluntarily recalling one lot of product due to particulate matter.
The company is voluntarily recalling liquid products due to possible Burkholderia cepacia contamination.
The three-year report emphasizes the roll of collaboration in drug safety.
August 04, 2016
The report addressed how the agency might support medicine development for patients’ unmet medical needs.