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 It’s Tricky – FDA’s New Draft Guidance Provides Updated Recommendations on How to Best Use Data Monitoring Committees in Clinical Trials

The FDA Law Blog

The new draft guidance is generally reflective of these developments, and we wanted to highlight several of the changes in this blog post. In 2006, FDA stated that DMCs were not recommended “for most clinical studies,” particularly those in early product development, short-term studies, or studies addressing less severe outcomes.

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FDA Unveils Its Own Medical Queries—A Standardized Approach for Grouping MedDRA Preferred Terms that Will Impact NDA/BLA Safety Analyses and Drug Labeling

The FDA Law Blog

By Ellis Unger, Principal Drug Regulatory Expert — On September 14, 2022, FDA/CDER/Office of New Drugs, in collaboration with the Duke-Margolis Center for Health Policy, hosted a virtual meeting on advancing premarket safety analytics , including sessions on new FDA Medical Queries and standardized presentations of safety data.

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

The FDA Law Blog

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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PharmDs – Crucial to Chronic Care Management Services: A Doctor’s Perspective

PharmD Live

According to the FDA, there are over 20,000 medications approved. A pharmacist who can review the additional added medications and ensure no adverse reactions are expected, and no drug interactions considerably lowers the risk to this population. Back to Main Blog. About the author.

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Decentralized Clinical Trials: The Future of Clinical Research

Roots Analysis

Such trials make use of software applications, monitoring devices and online social media engagement platforms to conduct the complete clinical trial process, including recruitment , patient engagement, counseling, informed consent, electronic data capture, measuring clinical endpoints and adverse reactions, as per the patients’ comfort.

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Low Dose Naltrexone and Hashimoto’s

The Thyroid Pharmacist

You may be familiar with naltrexone, which is an FDA-approved medication that has been used since the 1980s for opioid withdrawal. IW: What are some of the more common adverse reactions that people have to LDN? It is used at a higher, standard dose of 50 mg per day. That allows us to figure out the correct dose for each person.

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

The FDA Law Blog

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%. FDA took issue with that presentation considering that the product has boxed warnings for hepatotoxicity and QT prolongation which can cause death.