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Every Claim You Make, Every Step You Take…CVM Will Be Watching You

FDA Law Blog: Biosimilars

Further, information presented on the adverse reaction data was inconsistent with the PI. The Warning Letter alleged that the veterinarian product website made claims about a Vaccine Safety Study relied upon for approval that directly conflict with the PI. that it is effective on Day 1) and insinuating misleading comparative claims.

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Future of the Safe Step Act

Putting Patients First Blog

Other Blogs: Future of the Safe Step Act 04/04/2024 Read More Guest Post: Now is the Time to Act for Patients 04/03/2024 Read More Guest Blog: Heart Valve Disease Awareness 04/01/2024 Read More The post Future of the Safe Step Act appeared first on National Health Council.

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How authentication of drugs has become a fundamental pillar of patient safety

Express Pharma

This widespread issue has led to treatment failures, adverse reactions, and even loss of life among patients. Counterfeit drugs, intentionally mislabeled or misrepresented, often contain substandard or harmful ingredients, incorrect dosages, or no active ingredients at all.

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How to Run DMC? It’s Tricky – FDA’s New Draft Guidance Provides Updated Recommendations on How to Best Use Data Monitoring Committees in Clinical Trials

FDA Law Blog: Biosimilars

The new draft guidance is generally reflective of these developments, and we wanted to highlight several of the changes in this blog post. DMC charters have also grown longer and more detailed.

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Future of the Safe Step Act

Putting Patients First Blog

Other Blogs: Future of the Safe Step Act 04/04/2024 Read More Guest Post: Now is the Time to Act for Patients 04/03/2024 Read More Guest Blog: Heart Valve Disease Awareness 04/01/2024 Read More The post Future of the Safe Step Act appeared first on National Health Council.

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OPDP Says TV Ad is Out of Bounds with Fourth Untitled Letter of 2024

FDA Law Blog: Biosimilars

This letter, dated August 29, 2024, (at the height of the US Open, no less) comes not even a month after OPDP’s last letter from August 1, and a little over a month since another celebrity-related Untitled Letter, both of which we blogged about here.

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Lizzo has Thoughts: First Untitled Letter for Promotional Activities in a Yearwass

FDA Law Blog: Biosimilars

It has boxed warnings for hepatoxicity and QT prolongation and is contraindicated in numerous patient populations and has 17 adverse reactions with an incidence of >20%. We’ve blogged on this previously almost exactly a year ago (we did a slightly better job on not offending pop culture).