Medical Innovation Exchange

Regulatory Affairs

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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Enforcement Update: OPDP Issues Untitled Letter

We are four months into the year, and this week OPDP has issued its fourth regulatory action letter of 2022. Two of the previous were Warning Letters, considered the more serious of the two categories, and two, including the latest, were Untitled Letters. As noted in past updates, FDA’s OPDP enforcement letters have dropped off …

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New Landscape for the Old Pandemic

Tectonic pandemic plates are shifting respecting the COVID-19 pandemic. For weeks now we have been watching caseloads in the United States broadly fall. It feels as if we are indeed shifting gears. There are other moving parts that are in motion as well. It is a fundamental re-shifting of the landscape. And there are consequences. …

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Are We Moving On From Covid?

Mask mandates are dropping like flies. Restrictions are being lowered. In my observation, it feels that they are going to the wayside not only because of dropping caseloads, but also because people are just more than ready to move on. There may be some complacence – a feeling that the ubiquitous Omicron has fostered a …

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