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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.
September 27, 2021
The lack of a new permanent commissioner has hampered FDA in articulating future priorities and pushing back against miscommunications and outside complaints.
Biosimilar approvals and the advance of biosimilar testing and production may lead to greater access to alternative therapies.
September 24, 2021
GSK has received a positive recommendation from the EMA’s CHMP for Nucala (mepolizumab) to be used as a treatment in three additional eosinophil-driven diseases.
Celltrion Group has been granted approval for regdanvimab (CT-P59) to be used as a treatment for COVID-19 by the Korean Ministry of Food and Drug Safety (MFDS).
September 23, 2021
The first and only approved antibody-drug conjugate for the treatment of recurrent or metastatic cervical cancer with disease progression on or after chemotherapy receives accelerated approval by FDA.
Verrica Pharmaceuticals receives CRL from FDA identifying deficiencies at a facility of a CMO for its NDA for VP-102.
September 21, 2021
US District Court for the Middle District of Florida entered a consent decree of permanent injunction prohibiting Florida-based Premier Pharmacy Labs from producing or distributing drugs because of insanitary conditions.
The agency approved Byooviz (ranibizumab-nuna), a biosimilar to Lucentis (ranibizumab injection), for the treatment of several eye diseases.
Pfizer-BioNTech announced plans to seek FDA approval this month of a smaller dose of its Comirnaty vaccine for children ages 5–11.
September 20, 2021
FDA advisors agreed unanimously on a more limited booster plan after rejecting Pfizer’s original request to authorize its third shot for everyone over age 16.