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Skinny Label and Induced Infringement: The Saga Continues

The FDA Law Blog

GSK skinny label case , the U.S. Specifically, the Government explained, “[t]he section viii pathway cannot function properly if FDA and generic manufacturers cannot rely on an NDA holder’s representations to the agency regarding which portions of the brand-name drug’s labeling teach patented methods of use.”

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How to decode prescription labels for your patients

The Checkup by Singlecare

If you’ve worked in a community pharmacy, you’ve likely had the same frustrating conversations about prescription labels over and over. Due to variability in health literacy, studies show that Americans’ level of understanding of prescription label instructions ranges from 53% to 89%.

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Top 5 takeaways from international hybrid and virtual meeting guidance for pharma

pharmaphorum

Since COVID-19 reared its head more than two years ago, the traditional hustle and bustle of in-person annual congresses have largely been consigned to the history books. The existing IFPMA, EFPIA, and PhRMA codes cover the appropriate communication of promotional and non-promotional information during international congresses.

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Aduhelm approval controversy dials up as FDA seeks probe

pharmaphorum

The acting FDA commissioner has sent a letter to the Department of Health and Human Services (HHS) inspector general Christi Grimm on Friday, asking for a review of the communications between the FDA and the company and the process that led to the approval of Aduhelm (aducanumab).

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Antidepressants and Suicide: Why Don’t People Think There’s a Link?

The People's Pharmacy

Many years ago, in our book, Graedons’ Best Medicine (1991), we wrote about the evolution of Prozac: “When Prozac (fluoxetine) was introduced in 1987 it barely made a splash. ” Keep in mind that section in our book, Graedons’ Best Medicine, was written in 1990, just a couple of years after Prozac was approved.

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Resourceful or risky? The UK’s controversial COVID-19 vaccine strategy

pharmaphorum

I DID NOT consent to receive an off-label drug with NO evidence of benefit with a single dose. pic.twitter.com/ZDtIjm1z8W. — Dr Katrina Farrell (@farrell_katrina) December 31, 2020. The British Medical Association (BMA) also blasted the decision as “unreasonable and totally unfair”.

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Resourceful or risky? The UK’s controversial COVID-19 vaccine strategy

pharmaphorum

I DID NOT consent to receive an off-label drug with NO evidence of benefit with a single dose. The NHS Confederation, which represents leaders across the organisation, told pharmaphorum the government needed to be very clear in its communications with the public about exactly what they are being asked to do and why. “We