European Pharmaceutical Review
JULY 25, 2022
The European Commission (EC) has issued a draft proposal for a new EU Regulation on blood, tissues and cells (BTC) to help increase the safety and quality of substances of human origin (SoHO). The EC noted that the EDQM’s standards “will now become the primary means to meet the EU standards of quality and safety for BTC.”.
Pharma Marketing Network
JULY 27, 2022
The IMPORTANCE of PHARMACOVIGILANCE Safety Monitoring of Medicinal Products. Reach out at swhite@xaviercreative.com. Connect at linkedin.com/in/sunnywhite/ . REFERENCES: Organization, World Health. Accessed June 18, 2022. The post Personalizing the Cancer Patient Journey appeared first on Pharma Marketing Network.
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European Pharmaceutical Review
DECEMBER 1, 2022
GlobalData stated that if development is successful for Ultragenyx’s OTX-2002 , which has potential to be the first programmable epigenetic medicine, it could generate $1.6 Robust analytical methods are needed to establish safety, potency, and purity of mRNA therapeutics in large-scale manufacturing. billion during 2028.
pharmaphorum
DECEMBER 14, 2022
Sodium oxybate — which in the late 1980s was marketed to bodybuilders and then became known as GHB and criminally used as a date rape drug — has been sold under the brand name Xyrem after gaining FDA approval in 2002. Two decades of exclusivity.
European Pharmaceutical Review
JULY 20, 2023
Covered SoHO activities are “action[s], or series of actions, that [have] a direct impact on safety, quality or efficacy of SoHOs.” This will enable better monitoring of the safety and quality of these products, but it may also require additional investments in IT infrastructure.
European Pharmaceutical Review
NOVEMBER 15, 2022
The validation of computerized systems should be focused on ‘intended use’ and scaled commensurate with the risks to patient safety, product quality and data integrity” The focus until now has too often been on compliance and not on quality. Takeaways from ISPE’s GAMP 5 Second Edition update. FDA, 2022. . About the authors.
pharmaphorum
AUGUST 24, 2022
.” Indivior paid $600 million to settle criminal fraud charges of improper marketing of Suboxone in 2020, and last year agreed another payment of $300 million to resolve civil claims brought by US states.
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