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.

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European Pharmaceutical Review

NOVEMBER 8, 2022

The new law will also require drug manufacturers to pay rebates to Medicare if they increase drug prices faster than consumer inflation. 3) policing anticompetitive settlements between competing drug manufacturers. Citizen Petitions before the FDA. 5) monitoring access to biosimilars. Senate Bill 562 (S.

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Food and Drug Administration Pharma Prescription Manufacturing 52

PM360

DECEMBER 20, 2023

market (source: IQVIA MIDAS, May 2023). At the same time, a “drug lag” persists in China for global pharmaceutical companies’ products. billion people in 2023). Pharmaceutical companies can sell drugs with free pricing in the GBA and Hainan Boao after obtaining foreign approval (e.g., in the U.S.

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Marketing Insurance Medical Manufacturing 105

PM360

APRIL 25, 2023

biosimilars market to date, the first of eight FDA-approved Humira (adalimumab) biosimilars launched in the United States in January after years of regulatory delays. Although AbbVie’s patent for Humira officially expired in 2016, the legal and regulatory delays paused competition for Humira until 2023. pharmaceutical industry.

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Marketing Competition Government Manufacturing 97

PM360

AUGUST 9, 2022

Needles cause patients pain, anxiety, pose safety risks, and for some people receiving injection therapy is a traumatic experience. The FDA 510(k) submission is expected to take place in Quarter 3 2023. Pharmaceutical manufacturers can customize the solution based on the brand’s objectives and patient population’s needs.

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Prescription Medical Side effects Patients 105