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Human Drugs

Comments on Increasing Access to Non-Prescription Drugs

Four stakeholders comment to FDA on ways to increase patient access to nonprescription drugs.

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Biologics

FDA to Convene Panel on Modernas mRNA Flu Vaccine

FDA announces a 6/18 advisory committee meeting to review Modernas controversial mRNA-based seasonal influenza vaccine.

Biologics

RFK Jr. Ignores Hill Request on Anti-Vax Activist HHS Role

HHS secretary Robert F. Kennedy Jr. faces renewed scrutiny from Senate Democrats for ignoring requests about the role of longtime anti-vaccine activis...

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Human Drugs

Lilly Says Retatrutide Delivered Up to 30% Weight Loss

Eli Lilly reports that its investigational obesity drug retatrutide produced weight-loss results approaching those historically associated with bariat...

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Human Drugs

Clarity Sought on FDA New Approach Methodologies Guide

Stakeholders suggest ways FDA could clarify a draft guidance on using new approach methodologies in drug development.

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Medical Devices

React Health Recalls Ventilators Due to Manufacturing Issue

React Health recalls certain VOCSN V+Pro ventilators due to a manufacturing issue that could lead to undetected oxygen leaks and potentially cause ser...

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Human Drugs

All India Institute Clinical Trial Issues

FDA warns Dr. Sourav Mishra about violations in his conduct of a clinical investigation at the All India Institute of Medical Sciences in Bhubaneswar,...

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Human Drugs

Naseem Jaffrani BIMO Violation

FDA warns Alexandria, LA-based cardiologist Naseem Jaffrani about his failure to conduct a clinical investigation according to the investigational pla...

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FDA General

Will the Next Commissioner Learn from Makarys Mistakes?

Former FDA associate commissioner Peter Pitts says FDA has an opportunity with the resignation of commissioner Marty Makary to reset its operation and...

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Biologics

FDA Has to Build CRISPR Edit Review Protocol

A Clinical Trial Vanguard post describes the issues facing FDA in determining how to review and approve a BLA for a one-time CRISPR gene edit to addre...