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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 It’s Tricky – FDA’s New Draft Guidance Provides Updated Recommendations on How to Best Use Data Monitoring Committees in Clinical Trials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The new draft guidance is generally reflective of these developments, and we wanted to highlight several of the changes in this blog post. DMC charters have also grown longer and more detailed.

FDA 105
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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

For a number of years, FDA has been including groups of related preferred terms in tables in the Adverse Reactions Section of drug labeling (Section 6), generally describing such groupings with the use of footnotes. The problem is that adverse reactions are generally broader than a single preferred term.

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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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COVID-19: What to think of the J&J vaccine?

The Infectious Pharmacist

You don’t write me blogs… any moooooooore.”. I’d like to say it’s because I was on my first worldwide blog tour, but really it was just about being busy. <Cue > I have heard from several readers who said that my blog convinced them and their friends and family to get vaccinated. .> Cue Barbara Streisand!

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Medical Device Coating and Surface Modification Technologies: Current Market Landscape and Emerging Opportunities

Roots Analysis

Surface Modification Technologies and Coating Solutions: Current Market Landscape Coating materials must be selected in such a way that they reduce the chances of adverse reactions when they interact with the surroundings of the medical device.

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Shanghai ISPE Pharmaceutical Information Company holds 2022 China Pharmaceutical Supply Chain Summit

ISPE

Wang Fang min, Chairman of Project and Alliance Management, Shanghai Pharmaceutical and Medical Device Adverse Reaction Monitoring Center;Ms. Lynn Wang, Head of Project and Alliance Management of Wuxi Bio;Ms. Zhang Nan, General Manager of Thermo Fisher Science and Technology; Ms. Shi Yun, QA Manager of Restone Biomedicine Co.,

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2022 ISPE China Pharmaceutical Supply Chain Summit

ISPE

2022 ISPE China Pharmaceutical Supply Chain Summit Trudy Patterson Tue, 03/28/2023 - 09:24 iSpeak Blog iSpeak 2022 ISPE China Pharmaceutical Supply Chain Summit 28 March 2023 On 17 December 2022, more than 100 people from all over the world gathered online for the 2022 ISPE China Pharmaceutical Supply Chain Summit.