2021 Pharmaceutical manufacturing Safety 
Pharma Leaders
MAY 8, 2023
The Food and Drug Administration (FDA) has successfully inspected Nexus Pharmaceuticals’ pharmaceutical manufacturing facility located in Pleasant Prairie, Wisconsin, US. The inspection will allow the company to commence commercial operations at the three-storey, 84,000ft² manufacturing facility.
World of DTC Marketing
AUGUST 12, 2022
In 2021 alone, the top U.S. pharmaceutical companies booked tens of billions of dollars in revenue: Johnson & Johnson ($94 billion), Pfizer ($81 billion), AbbVie ($56 billion), Merck & Co. ($49 First, let’s clarify how the bill saves taxpayers billions. 49 billion), and Bristol Myers Squibb ($46 billion). . ($49
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European Pharmaceutical Review
MARCH 13, 2024
FDA inspections Identification of data integrity deviations Of the 70 Warning Letters issued by the US Food and Drug Administration (FDA) so far in 2024, three have identified data integrity issues at pharmaceutical manufacturing sites outside the US. References Warning Letters.
European Pharmaceutical Review
NOVEMBER 8, 2022
Pharmaceutical manufacturers have submitted Citizen Petitions raising safety or efficacy concerns about proposed competing generic and biosimilar products, and such submissions often delay FDA approval of the proposed products while the FDA resolves the pending petitions. 2(1)(B)(i) (2021), [link] senate-bill/562/text.
European Pharmaceutical Review
JULY 25, 2022
Consequently, pharmaceutical manufacturers risk their reputation if impersonating products fail to deliver the expected quality or health impact. For manufacturers, this allows for greater protection of products courtesy of real-time tracking data and the ability to refine and secure supply chains by spotting weak links.
Impetus Digital
AUGUST 2, 2024
Unsurprisingly, the US FDA has reported a noticeable increase in the number of submissions that use AI/machine learning (ML) components in recent years; in 2021, they received more than 100 submissions wherein AI use was reported. Regulatory Compliance Regulatory frameworks are continuously evolving in the pharmaceutical industry.
PM360
DECEMBER 20, 2023
At the same time, a “drug lag” persists in China for global pharmaceutical companies’ products. Between 2017 and 2021, the median time difference between the first global approval and the approval in China was five years 1. In 2021, the out-of-pocket (OOP) cost accounts for 28% of the whole healthcare expenses compared to 15.4%
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