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Saying that operational consolidations are coming in support services, FDA commissioner Martin Makary asks the staff to view change with openness and optimism.

latest-news

The Associated Press reports that questions are being raised about some new members appointed to the CDC Advisory Committee on Immunization Practices based on their past statements or affiliations with groups promoting vaccine misinformation.

LATEST NEWS

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More FDA Operational Changes Coming: Makary

Saying that operational consolidations are coming in support services, FDA commissioner Martin Makary asks the staff to view change with openness and optimism.

motusgi
Questions Raised on New ACIP Members

The Associated Press reports that questions are being raised about some new members appointed to the CDC Advisory Committee on Immunization Practices based on their past statements or affiliations with groups promoting vaccine misinformation.

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Medtronic Newport Ventilator Recall Class 1

FDA says a Medtronic recall of specified Newport ventilators is Class 1.

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Researchers Challenge FDA Lamictal Safety Warning

Rutgers University researchers say they have determined that the GlaxoSmithKline anti-seizure drug Lamictal is safe for adults with epilepsy and concomitant heart issues and does not warrant the FDA safety warning it was given in 2020.

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Animal Drugs

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medical-devices
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Researchers Challenge FDA Lamictal Safety Warning

Rutgers University researchers say they have determined that the GlaxoSmithKline anti-seizure drug Lamictal is safe for adults with epilepsy and conco...

medical-devices
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GSK Plans for Antibiotic NDA in 2nd Half

GSK plans to submit an NDA in the second half of the year after it and Spero Therapeutics announced that they will end their Phase 3 PIVOT-PO clinical...

medical-devices
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Prothena Scraps Birtamimab After Phase 3 Miss

Prothena discontinues the development of birtamimab, its investigational treatment for AL amyloidosis, after the drug failed to meet primary or second...

medical-devices
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Interchangeability for Celltrion’s Humira Biosimilar Expanded

FDA grants an expanded interchangeable designation for Celltrion’s Yuflyma (adalimumab-aaty), a biosimilar copy of AbbVie’s Humira.

Biologics

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medical-devices
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Questions Raised on New ACIP Members

The Associated Press reports that questions are being raised about some new members appointed to the CDC Advisory Committee on Immunization Practices ...

medical-devices
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Novavax Vaccine OK'd After Political Interference: JAMA

A JAMA viewpoint article raises alarms about FDA’s full approval last month of Novavax’s Covid-19 vaccine and the agency’s unusual delay and political...

medical-devices
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Makary Struggles to Clarify New Covid Recommendations

FDA commissioner Marty Makary appears to struggle to convey the government’s Covid-19 vaccine recommendations in a contentious interview on CBS’s Face...

medical-devices
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CBER’s Prasad Outlines Rare Disease Goals

CBER director Vinay Prasad outlines his expectations for advancing rare disease products, such as embracing both surrogate endpoints for accelerated a...

FDA General

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medical-devices
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More FDA Operational Changes Coming: Makary

Saying that operational consolidations are coming in support services, FDA commissioner Martin Makary asks the staff to view change with openness and ...

medical-devices
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CDC, NIH Staff Protest Trump Administration Chaos

Current and former CDC employees rally outside the agency’s Atlanta headquarters yesterday over Trump Administration-inspired chaos affecting the heal...

medical-devices
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Contaminated Zicam and Orajel Lots Recalled

Due to contamination concerns, Church & Dwight recalls all lots of Zicam Cold Remedy Nasal Swabs, Zicam Nasal AllClear Swabs, and Orajel Baby Teething...

medical-devices
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Makary/Prasad Priorities for ‘A New FDA’

FDA commissioner Martin Makary and CBER director Vinay Prasad use a JAMA article to list their five priorities for what they call a new FDA.

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Federal Register

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PDUFA Public Meeting for User Fee Reauthorization

Federal Register notice: FDA announces a 7/14 public meeting to discuss proposed recommendations for...

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Generic Drug Fee Program Reauthorization Meeting

Federal Register notice: FDA hosts a 7/11 public meeting on the reauthorization of the Generic Drug ...

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FDA Withdraws and Reissues 2 Guidances

FDA says it is withdrawing two recent final guidances on cell- and tissue-based products and reissui...

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CDER Continues Quality Management Program

Federal Register notice: FDA seeks drug manufacturing establishments to participate in the second ye...

Human Drugs

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Capricor Gets Form-483 After BLA Facility Inspection

A recent FDA pre-license inspection of Capricor Therapeutics’ San Diego manufacturing facility for i...

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FDA Approves UroGen Bladder Cancer Therapy

FDA approves a UroGen Pharma NDA for Zusduri (mitomycin intravesical solution) for adult patients wi...

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Sumitomo Gets Fast Track Status for Nuvisertib

FDA grants Sumitomo Pharma America a fast track designation for nuvisertib (TP-3654) and its use in ...

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Amish Origins Marketing Unapproved Drugs: FDA

FDA warns Worland, WY-based Amish Origins Management about CGMP violations in its manufacturing of u...

Marketing

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Attorney Warns: FDA Watching Professional Promotion

Attorney Nathan Downing says medical product companies should review their professional promotions a...

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RFK Jr. Attacks ‘Corrupt’ Drug Firms and DTC Ads

In a 5/27 podcast interview, HHS secretary Robert F. Kennedy Jr. continues his verbal assault agains...

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Sen. Durbin Queries FDA on Drug Promo Staff Cuts

Senator Dick Durbin (D-IL) asks FDA commissioner Marty Makary how CDER’s Office of Prescription Drug...

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FDA Warns Sarfez About Soaanz Promotional Materials

The CDER Office of Prescription Drug Promotion warns Sarfez Pharmaceuticals that promotional materia...

Medical Devices

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Medtronic Newport Ventilator Recall Class 1

FDA says a Medtronic recall of specified Newport ventilators is Class 1.

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Viz.ai Subdural Hemorrhage Quantifier Cleared

FDA clears a Viz.ai 510(k) for the Viz Subdural Plus, which the company describes as the “first and ...

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More Comprehensive AI Regulation Needed: Report

U.S. and Canadian AI researchers call on FDA to develop a more comprehensive regulatory framework fo...

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Baxter Recalls Novum IQ Syringe Pump

Baxter recalls its Novum IQ large volume pump after becoming aware of the potential for underinfusio...