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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.
November 01, 2022
A possible change in leadership on Capitol Hill has aggravated fears of political push-back on FDA regulation and approval of contraceptives and other medications.
October 26, 2022
AstraZeneca’s Imjudo (tremelimumab) was approved by FDA in combination with Imfinzi (durvalumab) for treating unresectable liver cancer.
An advisory committee’s vote to remove Makena from the market illustrates how difficult it is for regulators to ensure that such drugs document safety and effectiveness in a timely manner.
South Africa’s vaccine regulator has reached new WHO level to ensure safety, quality, and effectiveness.
October 21, 2022
The agency has recommended approval of Comirnaty and Spikevax for children from six months of age.
The agency has recommended authorization of the Spikevax COVID-19 vaccine that targets the Omicron variants BA.4 and BA.5.
October 19, 2022
Ebvallo (tabelecleucel) would be the first EMA-approved therapy for patients with relapsed or refractory Epstein-Barr virus positive post-transplant lymphoproliferative disease.
Takeda’s dengue vaccine is designed to prevent disease caused by virus serotypes 1, 2, 3, and 4 in individuals four and older.
October 18, 2022
In this episode, Ana Ladino provides expert insight into novel excipients in the current and future drug development landscape.
October 15, 2022
The authors discuss the differences in mechanism of activation of N-nitrosamides versus N-nitrosamines and the fact that they should not be treated the same.