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InfuTronix recalls its Nimbus infusion pump systems due to multiple potential failure modes that may include battery failure, upstream blockage (occlusion), and system errors, among other problems.

latest-news

FDA grants fast track designation to Compass’ CTX-009 that is in a Phase 2 study with paclitaxel to treat some biliary tract tumors.

LATEST NEWS

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InfuTronix Recalls Malfunctioning Infusion Pumps

InfuTronix recalls its Nimbus infusion pump systems due to multiple potential failure modes that may include battery failure, upstream blockage (occlusion), and system errors, among other problems.

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FDA Fast Track for Compass Biliary Tract Cancer Drug

FDA grants fast track designation to Compass’ CTX-009 that is in a Phase 2 study with paclitaxel to treat some biliary tract tumors.

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Cancer Trial Eligibility Criteria Guidance

FDA publishes a draft guidance to help sponsors expand eligibility for cancer drug clinical trials in terms of washout periods and concomitant medication exclusions.

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Electronic Signatures Info Collection Approved

Federal Register notice: FDA announces that OMB has approved an information collection entitled “Electronic Records: Electronic Signatures.”

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Animal Drugs

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medical-devices
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Pediatric Brain Tumor Therapy Approved

FDA grants Day One Biopharmaceuticals accelerated approval for Ojemda (tovorafenib), a Type 2 RAF inhibitor for treating patients six months of age an...

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FDA releases a draft guidance entitled “Manufacture of Batches in Support of Original NADAs, ANADAs, and CNADAs.”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

Biologics

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medical-devices
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Priority Review for Jemperli sBLA

FDA accepts for priority review a GSK supplemental BLA for Jemperli (dostarlimab) for combination use with standard-of-care chemotherapy (carboplatin ...

medical-devices
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‘Complete Response' on Abeona’s PZ-Cel BLA

FDA issues Abeona Therapeutics a complete response letter on a BLA for prademagene zamikeracel (pz-cel), requesting additional information to satisfy ...

medical-devices
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Alvotech/Teva’s Stelara Biosimilar Approved

FDA approves Alvotech and Teva Pharmaceuticals’ Selarsdi (ustekinumab-aekn) injection for subcutaneous use, a biosimilar to Johnson & Johnson’s Stelar...

medical-devices
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GSK BLA Accepted for Meningococcal Vaccine

FDA accepts for review a GSK BLA for its 5-in-1 meningococcal ABCWY vaccine candidate.

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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Electronic Signatures Info Collection Approved

Federal Register notice: FDA announces that OMB has approved an information collection entitled “Ele...

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Promo Labeling Guide for Biologic Products

Federal Register notice: FDA makes available a revised draft guidance entitled “Promotional Labeling...

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23 No-Longer-Marketed NDAs Withdrawn

Federal Register notice: FDA withdraws the approval of 23 NDAs from multiple applicants because they...

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Annual Report on Postmarketing Requirements

Federal Register notice: FDA makes available its annual report entitled “Report on the Performance o...

Human Drugs

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FDA Fast Track for Compass Biliary Tract Cancer Drug

FDA grants fast track designation to Compass’ CTX-009 that is in a Phase 2 study with paclitaxel to ...

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Cancer Trial Eligibility Criteria Guidance

FDA publishes a draft guidance to help sponsors expand eligibility for cancer drug clinical trials i...

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Fresenius Recalls Stay-Safe Catheter Sets

Fresenius Medical Care recalls its Stay-Safe Catheter Extension Sets and Stay-Safe/Luer Lock Adapter...

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Cancer Trial Performance Status Eligibility Criteria

FDA publishes a draft guidance on using patient performance status as eligibility criteria for cance...

Marketing

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Biological Promotion Q&A Guidance

FDA publishes a draft guidance with questions and answers on promotional communications for some pre...

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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...

Medical Devices

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InfuTronix Recalls Malfunctioning Infusion Pumps

InfuTronix recalls its Nimbus infusion pump systems due to multiple potential failure modes that may...

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FDA Tightening ‘Research Use Only’ Tests: Lawyers

Three SheppardMullin attorneys say that manufacturers of tests labeled for research use only should ...

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Curio Postpartum Depression Device Cleared

FDA clears a Curio Digital Therapeutics 510(k) for its MamaLift Plus, a prescription digital therape...

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FDA Launches ‘Home as a Healthcare Hub’

FDA launches a collaboration to develop a Home as a Healthcare Hub prototype to help patients, healt...