Pharma Marketing Network
JULY 27, 2022
It is too soon to say if the healthcare industry is on the verge of adopting a retail-style customer focus, however, if we learned anything from the pandemic, it is that patients now realize so much more is possible. How will healthcare respond? The IMPORTANCE of PHARMACOVIGILANCE Safety Monitoring of Medicinal Products.
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.”.
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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. Jason Peterson RPh is a clinical pharmacist at RemedyOne, with over 25 years of experience in healthcare and pharmacy.
pharmaphorum
AUGUST 24, 2022
The state alleges that the drugmaker made false and misleading claims that Suboxone film was less subject to diversion and abuse, and less likely to be accidentally swallowed by children, blocking generic competition that would have reduced pressure on healthcare budgets during an epidemic of opioid abuse.
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.
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
SEPTEMBER 22, 2023
Active immunotherapy through vaccination has a far lower cost than mAb-based therapies, representing an important decrease of economic burden for healthcare systems at a global scale. 7 It is currently being evaluated in a Phase Ib/IIa clinical study, demonstrating to date a good safety profile.
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