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Medical Devices

Megadyne Recalls Pediatric Return Electrodes

Megadyne recalls its Megadyne Mega Soft Pediatric Patient Return Electrodes after receiving reports about patients being burned during electrosurgery ...

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Human Drugs

3 Bayesian Examples Added to Demonstration Project

FDA adds three Bayesian statistical analysis examples to the CDER Center for Clinical Trial Innovation Web page.

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Human Drugs

Supreme Court Rejects Mifepristone Lawsuit

The U.S. Supreme Court 6/13 unanimously rejects a lawsuit seeking to sharply restrict distribution of the chemical abortion pill mifepristone (Dancos ...

Biologics

FDA Revises Covid Vaccine Composition Recommendation

FDA updates its advice on this falls Covid-19 vaccine composition based on a recent review of circulating Covid cases in the U.S.

Biologics

Submit Long Covid Drug as IND: FDA

FDA says Revive Therapeutics should submit an IND for a clinical trial of its bucillamine as a treatment for Long Covid.

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Federal Register

Drug Distribution Security Comment Period Reopened

Federal Register notice: FDA reopens the comment period on an 11/20/2023 request for information that is intended to better understand the status of t...

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Federal Register

Info Collection on Drug Compounding

Federal Register notice: FDA seeks comments on an information collection extension entitled Human Drug Compounding, Repackaging, and Related Activitie...

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Human Drugs

5 Teva ProAir Patents Ordered Out of Orange Book

A New Jersey federal judge orders five Teva ProAir patents removed from the FDA Orange Book.

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Human Drugs

FDA Platform Technology Designation Analyzed

Two Morgan Lewis attorneys analyze a recent FDA guidance on how it will implement its drug platform technology designation program.

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Human Drugs

Positive Results for Setrusumab in Bone Disease

Ultragenyx and BioMereo say their setrusumab showed positive results in the Phase 2 portion of the Orbit study in patients with the complex bone and t...