Tag Archives: FDA

For FDA and CDC and the Rest of Us – The Stakes Have Never Been Higher

Since last week’s posting regarding FDA credibility being on the line, there has been a swirl of activity and commentary around the evaluation of vaccine research for COVID-19 that would seem to have exacerbated the problem. For context, last week … Continue reading

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Look Back – Drug Approvals First Half of 2020 Amidst the COVID Challenge

As the year began, no one really thought that within a few months, the systems upon which we rely on for just about everything would be so severely disrupted and tested by the presence of something we cannot even see … Continue reading

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AdComm Drop-off in 2019 – FDA Consults Fewer Experts in 2019

The system of FDA Advisory Committees is in place so that when FDA needs advice – either on policy development, reviewing an issue with an already approved medicine, or regarding new drug approvals – the agency has a lot of … Continue reading

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FDA OPDP Research – A Foggy Window into Future Thinking on Digital Media

When one thinks of FDA’s Office of Prescription Drug Promotion (OPDP) there is a likely tendency to think of the regulatory action letters – Warning Letters or Untitled Letters -issued by that office to pharmaceutical companies about their promotional communications. … Continue reading

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Enforcement Updates: OPDP Issues First Letter of the Year

In recent years, FDA’s Office of Prescription Drug Promotion (OPDP) has been diminished in the volume of its enforcement expressed through the issuance of Warning and Untitled Letters. OPDP now sends out only a handful of letters each year when … Continue reading

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