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STAT+: Q&A: How the FDA could use AI for drug and device safety surveillance

STAT

Sentinel draws upon clinical records and insurance claims, and the agency uses its analyses to adjust drug labels, convene advisory committees and disseminate drug safety communication, the authors noted. 

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FDA-Approved Labeling: Is Enough Enough?

FDA Law Blog: Biosimilars

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts.

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Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight

FDA Law Blog: Biosimilars

FDA regulations define a complaint expansively, to include “any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.” [2] establish and maintain adverse event files.” [9]

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FDA’s OPDP Issues Third Letter of 2023

Eye on FDA

The Untitled Letter posted this week involved an oral birth control pill which has a specific of contraindications contained in the label as well as a list of warnings and precautions and of the most common adverse events. The communications vehicle in question was a social media sponsored posting.

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It Finally Happened – FDA’s OPDP Issues First Letter of 2023

Eye on FDA

The label for the medicine includes a boxed warning regarding potential issues related to complications for the liver (toxicity) and heart (QT prolongation). Going back and looking through 2020 at the products involved in letters, there have been a total of 17 letters (involving 19 different communications vehicles).

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

pharmaphorum

When events moved online, societies and associations recognised the wider access afforded by “virtual”, and now, as the world slowly gets back on track, many have opted for a hybrid model that offers the best of both. Identifying the appropriate code and label. The same cannot be said for online events. The codes still apply.

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Sharing oncology trial PROs to build the treatment of the future

pharmaphorum

In the United States, the 21st Century Cures Act encouraged the Food and Drug Administration (FDA) to review and communicate patient experience data from trials – but the lack of a common framework for submissions and space on product labels has, until now, been something of a stumbling block. . Project Patient Voice .

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