Medical Innovation Exchange

Regulatory Affairs

Emerging from Emergency – Two COVID-Related Developments This Week

Two announcements occurred this week, both of note and connected only by the fact that they are emblematic of the slow metamorphosis from a COVID emergency world to a post-COVID emergency one. Emergency Ends – First, the Biden Administration announced that it would be allowing the Public Health Emergency (PHE) declaration to lapse this coming …

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What They Said – Looking Back at FDA Press Releases During 2022

Each year Eye on FDA provides a look-back to see what the agency was talking about and what has changed over time. This year is a telling one and FDA may be changing the nature of the way they are communicating with the public. Moreover, this year is marked by the fact that the agency …

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When the Going Gets Tough – FDA AdComms in 2022

Through its Human Drugs Advisory Committee process FDA has a vast array of outside experts to consult on matters related to product approval as well as questions about policy or safety issues concerning approved products. The mechanism provides an open and transparent process whereby people can see and hear the deliberations and have input during …

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Tick Tock re Tik Tok and FDA’s OPDP

Tik Tok was first released in 2016. While slow out of the starting gate with emergent media opportunities, in 2022, pharma is embracing the platform in both unbranded and branded efforts. While historically, a lot of Tik Tok use has been comprised of individuals releasing videos of them showing off dance moves and physique, the …

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A Single Source of Truth Helps Regulatory Teams

A Single Source of Truth Helps Regulatory Teams     Regulatory teams participate in every step of bringing a medical device or drug to market. Because of the essential role they play, these teams need advanced tools to keep pace with the latest regulatory bodies and standards. Legacy technology that siloes data across different pillars isn’t …

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OPDP Outlines New Research

FDA published notice recently that the Office of Prescription Drug Promotion (OPDP) was proposing some new research related to the promotion of medicines by pharmaceutical companies. The research was new (kind of) but the direction was more of the same old focus – direct-to-consumer advertising (DTC). First, just a note on why the research is …

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Device Labeling: Best Practices

Device Labeling: Best Practices     EU MDR required companies to make significant changes to their medical device labels, highlighting the need for a well-coordinated and agile device labeling process. We spoke with Laura Johnson, director of sales with Loftware, an enterprise labeling and artwork management provider, to discuss common pain points in label development and …

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What They Said – Looking Back the First 6-Months of FDA Communications

Periodically I write a posting to look back at what FDA is talking about to get some perspective. Each individual press release tells us something, but looking back at the aggregate can also provide insights. Not long ago, a retrospective look that compared the ratio and trend of COVID versus non-COVID related news out of …

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Here We Go Again – Monkeypox Communications Challenges

Source: CDC In February 2020 I published a blog posting – Emerging Pathogens, Communications – that encapsulated my observations and learnings from my years work in the early years of the HIV/AIDS pandemic in the early 1980s. As we sit, possibly, on the cusp of another large scale medical challenge with monkeypox, it seemed like …

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Speaking of Medicine – Mid-Year OPDP Enforcement Review

There are two means of gaining insight into the agency’s thinking about regulatory issues related to promotional communications by pharmaceutical companies; one is through the issuance of guidance documents, the other is through enforcement. But when it comes to enforcement things have changed greatly over the years. In 1998, there were 156 letters issued in …

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