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FDA issues a safety alert on unsafe counterfeit versions of AbbVie’s Botox (botulinum toxin) have been found in multiple states and administered to consumers for cosmetic purposes.

latest-news

FDA warns Soulaire Corp. that it is marketing an external counterpulsation system for unapproved uses, adulterating and misbranding the unit.

LATEST NEWS

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FDA Warns on Suspected Counterfeit Botox

FDA issues a safety alert on unsafe counterfeit versions of AbbVie’s Botox (botulinum toxin) have been found in multiple states and administered to consumers for cosmetic purposes.

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Soulaire Marketing Unapproved Device: FDA

FDA warns Soulaire Corp. that it is marketing an external counterpulsation system for unapproved uses, adulterating and misbranding the unit.

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2 CGMP Violations in Natco Pharma Inspection

FDA warns the Telangana, India-based Natco Pharma manufacturing facility about CGMP violations in its production of finished drugs.

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Clinical Trial Innovation Center Established

CDER establishes the Center for Clinical Trial Innovation to support innovative approaches to clinical trials that are designed to improve the quality and efficiency of drug development.

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Animal Drugs

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medical-devices
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Guide on Animal Drug Mfg. Batches

FDA releases a draft guidance entitled “Manufacture of Batches in Support of Original NADAs, ANADAs, and CNADAs.”

medical-devices
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2 Veterinary Medicine Guidances Published

The Center for Veterinary Medicine issues two guidances on data element submission.

medical-devices
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Animal Drug API GMP Guidance

FDA publishes a comprehensive Veterinary International Conference on Harmonization guidance on good manufacturing practice for animal drug APIs.

medical-devices
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Animal MUMS Drug Guidance

FDA publishes a guidance to assist sponsors in seeking approval of new animal drugs for minor uses or minor species.

Biologics

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medical-devices
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Enlivex Mixed Results of Sepsis Cell Therapy

Enlivex Therapeutics reports mixed results from its Phase 2 study of Allocetra in patients with sepsis.

medical-devices
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Mixed Data on Colon Cancer Vaccine

Gritstone Bio reports mixed data from an ongoing Phase 2 portion of a Phase 2/3 study evaluating Granite, a personalized neoantigen cancer vaccine for...

medical-devices
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Eisai sBLA for Monthly Alzheimer’s Maintenance

Eisai files a supplemental BLA for monthly Leqembi (lecanemab-irmb) intravenous maintenance dosing in Alzheimer’s disease patients.

medical-devices
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Medexus’ Hemophilia B Factor Gets Expanded Use

FDA approves a Medexus Pharmaceuticals supplemental BLA for Ixinity [coagulation factor IX (recombinant)] for treating pediatric patients under 12 yea...

FDA General

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medical-devices
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Califf in Hot Seat at 4/11 Oversight Hearing

The House Committee on Oversight and Accountability ratchets up political pressure on FDA by requesting commissioner Robert Califf’s testimony at a 4/...

medical-devices
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Poll Backs FDA Status Quo in Approving Products

In the wake of this week’s U.S. Supreme Court oral arguments on the abortion drug mifepristone, a new Axios/Ipsos poll finds that most Americans say t...

medical-devices
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Weiner Moves to Foreign Inspections Office

FDA Office of Combination Products associate director for policy John Weiner moves to Office of Global Operations director, where he will oversee the ...

medical-devices
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GAO Report Hits FDA on Investigator Retention

A new Government Accountability Office report says FDA needs to evaluate its recruitment and retention efforts to support and maintain its investigato...

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Federal Register

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Clinical Trial Innovation Center Established

CDER establishes the Center for Clinical Trial Innovation to support innovative approaches to clinic...

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Kemstro Not Withdrawn Due to Safety/Efficacy

Federal Register notice: FDA determines that UCB’s Kemstro (baclofen) orally disintegrating tablets,...

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Vistaril Not Withdrawn Over Safety/Efficacy

Federal Register notice: FDA determines that Pfizer’s Vistaril (hydroxyzine pamoate) oral suspension...

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Italfarmaco Awarded Priority Review Voucher

Federal Register notice: FDA issues a priority review voucher to Italfarmaco SpA for being the spons...

Human Drugs

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FDA Warns on Suspected Counterfeit Botox

FDA issues a safety alert on unsafe counterfeit versions of AbbVie’s Botox (botulinum toxin) have be...

motusgi
Read More
2 CGMP Violations in Natco Pharma Inspection

FDA warns the Telangana, India-based Natco Pharma manufacturing facility about CGMP violations in it...

motusgi
Read More
CDER Launches Trial Innovation Center

CDER announces the launch of its Center for Clinical Trial Innovation, which will focus on promoting...

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Clinical Hold on Neumora Study in Brain Diseases

FDA places a clinical hold on a Neumora Therapeutics Phase 1 clinical trial for NMRA-266 for treatin...

Marketing

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Methodological Rigor Info May Help Promotions: OPDP

CDER Office of Prescription Drug Promotion researchers say disclosing methodological rigor in commun...

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Disease Awareness Ads Can Confuse: FDA Study

CDER Office of Prescription Drug Promotion research demonstrates that consumers may be confused and ...

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Digital Drug Marketing Workshop Themes

A Duke-Margolis Institute for Health Policy report on an FDA-funded virtual workshop on drug digital...

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Industry Faults FDA Research on DTC ‘Implied Claims’

Industry stakeholders question the usefulness and design of proposed CDER Office of Prescription Dru...

Medical Devices

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Soulaire Marketing Unapproved Device: FDA

FDA warns Soulaire Corp. that it is marketing an external counterpulsation system for unapproved use...

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HeartMate Pumps Recalled Due to Obstructions

Abbott’s Thoratec unit recalls its HeartMate II and HeartMate 3 Left Ventricular Assist System due t...

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FDA Clears 3D Printed Cranial Implant

FDA clears a 3D Systems 510(k) for its 3D-printed, patient-specific cranial implant VSP PEEK Cranial...

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AI Software Authorized for Osteoporosis Screens

FDA grants 16 Bit Inc. a de novo marketing authorization for Rho, an AI-enabled software device aime...