FDA Webview
X
latest-news

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 approves an Xstim PMA for the Xstim Spine Fusion Stimulator for bone growth stimulation.

LATEST NEWS

View All
motusgi
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.

motusgi
Xstim Spine Fusion Stimulator Approved

FDA approves an Xstim PMA for the Xstim Spine Fusion Stimulator for bone growth stimulation.

motusgi
CBER Joining Lupus Research Consortium

FDA adds CBER to its partnership with the Lupus Accelerating Breakthroughs Consortium to better focus on engineered cell therapies.

motusgi
C&T Dream Co. CGMP Violations

FDA warns South Korea’s C&T Dream Co. about CGMP violations in its manufacturing of finished drugs.

newsletter-first

FDA Webview Free Daily e-Newsletter

Free Sign-Up

Animal Drugs

View All
medical-devices
Read More
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FDA releases a draft guidance entitled “Manufacture of Batches in Support of Original NADAs, ANADAs, and CNADAs.”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
Read More
2 Veterinary Medicine Guidances Published

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

medical-devices
Read More
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
Read More
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

View All
medical-devices
Read More
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
Read More
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
Read More
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
Read More
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

View All
medical-devices
Read More
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
Read More
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
Read More
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
Read More
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...

newsletter-second

FDA Webview Free Daily e-Newsletter

Free Sign-Up

Federal Register

View All
motusgi
Read More
Clinical Trial Innovation Center Established

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

motusgi
Read More
Kemstro Not Withdrawn Due to Safety/Efficacy

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

motusgi
Read More
Vistaril Not Withdrawn Over Safety/Efficacy

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

motusgi
Read More
Italfarmaco Awarded Priority Review Voucher

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

Human Drugs

View All
motusgi
Read More
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
CBER Joining Lupus Research Consortium

FDA adds CBER to its partnership with the Lupus Accelerating Breakthroughs Consortium to better focu...

motusgi
Read More
C&T Dream Co. CGMP Violations

FDA warns South Korea’s C&T Dream Co. about CGMP violations in its manufacturing of finished drugs.

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...

Marketing

View All
motusgi
Read More
Methodological Rigor Info May Help Promotions: OPDP

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

motusgi
Read More
Disease Awareness Ads Can Confuse: FDA Study

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

motusgi
Read More
Digital Drug Marketing Workshop Themes

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

motusgi
Read More
Industry Faults FDA Research on DTC ‘Implied Claims’

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

Medical Devices

View All
motusgi
Read More
Xstim Spine Fusion Stimulator Approved

FDA approves an Xstim PMA for the Xstim Spine Fusion Stimulator for bone growth stimulation.

motusgi
Read More
Soulaire Marketing Unapproved Device: FDA

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

motusgi
Read More
Ex-CEO Sentenced Over Phony Covid Test

A federal court sentences former Decision Diagnostics CEO Keith Berman to seven years in prison for ...

motusgi
Read More
HeartMate Pumps Recalled Due to Obstructions

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