article thumbnail

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.”

article thumbnail

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%.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

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.

article thumbnail

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).

FDA 52
article thumbnail

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.

FDA 81
article thumbnail

Ep. 002 – John Mack Podcast Transcript

Pharma Marketing Network

We may do some things like you were talking about where we have advertorials, and it’s clearly labeled as an advertorial. And do that, you interviewed me back in 2015, for the results book. I think you did an incredibly effective job of communicating what it’s like to live a life in this industry, from both sides.

article thumbnail

ChatGPT, BARD, and Other Large Language Models Meet Regulated Pharma

ISPE

In sections where we applied ChatGPT for example cases, we indicate this as such: The question or remark from us is labeled as Authors. This so-called zero-shot approach has the strong advantage that no data must be labeled for the tailoring step and that the same model can be used for many different NLP applications.