Category Archives: Safety

US Pharmacopeia Head Wants Fresh Outlook

In anticipation of the 200th anniversary of the United States Pharmacopeia (USP) in 2020, the organization’s new leadership is taking a fresh look at its role in setting standards for pharmaceutical development and production and how that has been altered by new regulatory policies and industry globalization. USP chief executive officer Ron Piervincenzi is consulting […]
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Pfizer–AstraZeneca: Implications for the Future of International Pharma

By Peter O’ Donnell. The Pfizer-AstraZeneca courtship raises many fascinating questions about the future shape of the international pharmaceutical industry, but it is also revealing some remarkable displays of parochialism. Even the olympian Financial Times has been displaying some nationalistic sympathies that sit oddly with its customary laissez-faire liberalism. A recent editorial seemed to argue strongly for some form […]
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The Fort Hood Killing and Psychotropic Drugs

In response to the recent shooting at Fort Hood that killed four (including the killer’s suicide) and wounded 16, the mental health watchdog Citizens Commission on Human Rights (CCHR) views this and other recent incidents as a wake-up call to the dangers of antidepressants, anti-psychotics and anti-anxiety drugs, which between them have accumulated 22 international drug […]
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Is Gender a Drug Safety Issue in the Era of Personalized Medicine?

By Lisa Henderson, Applied Clinical Trials. In January 2013, FDA told manufacturers to lower the dose of zolpidem, the insomnia treatment, for women, and suggested a 10 mg to 5 mg for immediate-release products (Ambien, Edluar, and Zolpimist) and from 12.5 mg to 6.25 mg for extended-release products (Ambien CR). That was based on evidence […]
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Adaptive Licensing: The Start of a Slow Revolution in Europe

By Peter O’ Donnell. So at last it’s happened. Adaptive licensing has leapt from the pages of learned journals into the real world of European regulation. Is this the beginning of the end of binary decision-making on the merits of a new medicine? Has a half-century of the “yes/no” authorization process peaked, to be replaced […]
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