Tag Archives: drug safety

FDA’s Patient Outreach: Finding Ties that Bind

Is the FDA doing enough to incorporate the patient perspective in the drug review process? This was the key question considered at a panel of regulatory experts held at last month’s annual BIO International Convention in San Diego. The consensus: while FDA deserves high marks for effort, both in reconciling the diversity of patient organization […]
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EMA to Review Safety of Ibuprofen Medicines

The European Medicine Agency’s Pharmacovigilance and Risk Assessment Committee (PRAC) has started a review to evaluate the cardiovascular risks with systemic ibuprofen medicines.
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FDA Targets Online Pharmacies

By Melanie Sena, Pharmaceutical Technology. FDA, in partnership with other federal and international agencies, has ┬átaken action against websites that sell potentially dangerous, unapproved prescription drugs to US consumers. FDA and the US Customs and Border Protection (CBP) also conducted examinations at US-based international mail facilities, where many packages containing prescription drugs enter the US, […]
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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┬árecent 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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