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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.
July 01, 2021
With COVID-19 vaccine facilities receiving recent citations, it is evident that failure to meet cleaning and sanitization requirements puts patients, facilities, and operators at risk.
June 29, 2021
EMA's CHMP has adopted a positive opinion recommending the approval of UCB’s bimekizumab (Bimzelx) for the treatment of plaque psoriasis.
Otsuka Pharmaceuticals Europe has filed an initial marketing authorization application to the European Medicines Agency for voclosporin.
June 28, 2021
Reports of myocarditis and pericarditis following Pfizer-BioNTech and Moderna vaccinations prompts warnings.
Pharmaceutical Technology discussed the potential increased risk of counterfeit medicines in the UK post-Brexit and how blockchain could be a useful tool to tackle the issue.
June 25, 2021
Amgen’s Aimovig has become the first and only approved treatment in Japan for treating migraine attacks in adults by blocking the CGRP-R.
FDA has granted breakthrough therapy designation to donanemab, Eli Lilly and Co.’s investigational antibody treatment for Alzheimer’s disease.
June 23, 2021
The European Commission has purchased an additional 150 million doses of Moderna’s COVID-19 vaccine for delivery in 2022.
Ilya Pharma has been granted approval by the Swedish Medical Product Agency and Swedish Ethical Review Authority for initiation of a Phase II clinical trial of its ILP100 gene therapy.
June 22, 2021
FDA's CDER has launched an initiative to gain more efficient and transparent operations of its advisory panels.