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Medical Devices

Draft Device Human Factors Guidance

FDA publishes a draft guidance on the content of human factor and usability engineering information to be included in medical device marketing submiss...

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Human Drugs

Comments on Pediatric Clinical Pharmacology Draft

Two stakeholder associations comment on an FDA draft guidance on general clinical pharmacology considerations for pediatric studies of drugs.

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Medical Devices

Dewei Medical Recalls Sample Kits

Dewei Medical Equipment recalls its DNA/RNA Preservation Kits because the products were distributed to U.S. customers without FDA authorization, clear...

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FDA General

FDA Manuscript in the Works on Trial Diversity Strategy

FDA commissioner Robert Califf says the agency is preparing a manuscript to outline a strategy for getting more diversity into clinical trials.

Biologics

Moderna, Pfizer Bivalent Vaccine EUAs Amended for Young

FDA amends the emergency use authorizations of the updated (bivalent) Moderna and Pfizer-BioNTech Covid-19 vaccines for use in children as young as si...

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Human Drugs

FDA Denies Homeopathy Petition

FDA denies an Americans for Homeopathic Choice petition asking that some homeopathic drugs not be considered new drugs and thus not subject to premark...

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Biologics

Significant HCT/P Deviations at Cryos International

FDA warns Orlando, FL-based Cryos International about significant deviations from human cell, tissue, and cellular and tissue-based products regulatio...

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Human Drugs

Homeopathic Drug Products Enforcement Guide

FDA also says it expects that many homeopathic drug products will fall outside the categories of drug products that FDA intends to prioritize for enfo...

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Medical Devices

FDA Denies Petition on Scrubs as Medical Devices

FDA denies a petition filed by attorney James Czaban involving the regulation as medical devices of surgical scrubs for daily wear by healthcare worke...

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Human Drugs

PhRMA Issues with FDA Medical Queries

PhRMA urges FDA to work internationally to harmonize any change in the approach to premarket safety analytics.