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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.
December 11, 2020
Committee recommends Emergency Use Authorization of first mRNA-based COVID-19 vaccine; FDA approval is pending.
The European Commission has granted a license for the use of inclisiran (Leqvio) as a treatment of primary hypercholesterolemia or mixed dyslipidaemia in adult patients.
Celltrion Healthcare has announced that EMA's CHMP has issued a positive opinion for the marketing authorization of CT-P17—an adalimumab biosimilar.
The Vaccines Manufacturing and Innovation Centre (VMIC) has chosen Lonza’s MODA-EM solution for the digitalization of its microbiology quality control operations.
The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have published a joint strategy for medicines regulation in Europe over the next five years.
December 10, 2020
The European Medicines Agency has launched a full investigation into a cyberattack.
December 08, 2020
Pfizer-BioNTech details its case for Emergency Use Authorization for "highly effective" COVID-19 vaccine.
The product is being recalled because of Burkholderia cepecia contamination.
The new guidance document is intended to minimize medication errors and avoid violations of the FD&C Act.
The agency published guidance on how sponsors of combination products can obtain feedback from FDA on scientific and regulatory concerns.