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Former FDA head Scott Gottlieb appears on CNBC to throw his support behind commissioner-nominee Heidi Overton on the eve of her Senate confirmation hearing.

latest-news

FDA warns Phoenix, AZ-based Specialty Health Products about multiple violations in its marketing of unapproved colonic irrigation systems.

LATEST NEWS

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Gottlieb TV Appearance Endorses Overton FDA Nomination

Former FDA head Scott Gottlieb appears on CNBC to throw his support behind commissioner-nominee Heidi Overton on the eve of her Senate confirmation hearing.

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Multiple Types of Violations at Specialty Health Products

FDA warns Phoenix, AZ-based Specialty Health Products about multiple violations in its marketing of unapproved colonic irrigation systems.

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CBER Sponsor Regulatory Meetings SOPP

CBER issues a Standard Operating Policy and Procedure on scheduling and conducting regulatory meetings on drugs and biologics.

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FDA Consent Decree Against Gold Star Distribution

A federal court has entered a consent decree of permanent injunction against Gold Star Distribution, Inc., prohibiting the Minnesota warehouse operator from receiving, storing or distributing FDA-regulated products until it corrects persistent insanitary conditions

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Animal Drugs

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medical-devices
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Antimicrobial Animal Drug Finalized Safety Guidance

FDA issues a finalized guidance on evaluating the safety of antimicrobial animal drugs based on their role in human medicine.

medical-devices
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Petition Urges FDA to Restrict Antibiotic Use in Animals

A coalition of 65 health, environmental, consumer, farming, and animal welfare organizations petition FDA to withdraw approvals for the routine use of...

medical-devices
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FDA Authorizes 1st Generic Animal Drug for New World Screwworm

FDA authorizes Felix Pharmaceuticals’ generic nitenpyram tablets to treat New World screwworm infestations in dogs and cats.

medical-devices
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Open Letter to Trump Urges FDA Push on Rare Diseases

In an opern letter to president Trump, rare disease advocates urge him to push FDA to accelerate approvals for treatments targeting fatal genetic diso...

Biologics

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medical-devices
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CBER Sponsor Regulatory Meetings SOPP

CBER issues a Standard Operating Policy and Procedure on scheduling and conducting regulatory meetings on drugs and biologics.

medical-devices
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Are Comparative Clinical Studies of Biologics Worth the Time and Cost?

FDA says a meta-analysis performed by CDER scientists suggests that pharmacokinetic similarity studies can often yield sufficient information on biosi...

medical-devices
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FDA Wants New Survival Trial Before Compass Files Tovecimig BLA

FDA recommends that Compass Therapeutics conduct an additional clinical trial demonstrating an overall survival benefit before submitting a BLA for to...

medical-devices
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Interchangeable Product Development Strategy Outlined

FDA issues a strategy document summarizing discussions at a 2025 workshop on developing interchangeable biosimilar products.

FDA General

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medical-devices
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Gottlieb TV Appearance Endorses Overton FDA Nomination

Former FDA head Scott Gottlieb appears on CNBC to throw his support behind commissioner-nominee Heidi Overton on the eve of her Senate confirmation he...

medical-devices
Read More
FDA Consent Decree Against Gold Star Distribution

A federal court has entered a consent decree of permanent injunction against Gold Star Distribution, Inc., prohibiting the Minnesota warehouse operato...

medical-devices
Read More
Senate Urged to Question Overton on FDA's Scientific Decision-Making

FDA Matters blog author Steven Grossman urges the Senate HELP Committee to examine how FDA commissioner-nominee Heidi Overton intends to make regulato...

medical-devices
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Reg Update on Non-Animal Testing Methods in Drug Development

FDA has issued a direct final rule updating its regulations to clarify that non-animal testing methods may be used, where appropriate, to establish th...

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Federal Register

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FDA Moves to Cement Complete Response Letter Transparency Policy

FDA looks to formalize one of its most significant transparency initiatives in decades: the public r...

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FDA Warns Brazilian Drug Maker Over Records Request

FDA sends a Warning Letter to Brazilian over-the-counter drug manufacturer Aeroflex Industria de Aer...

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FDA Delays Review Action on Alzheimer’s Drug

FDA delays by three months its decision on Eisai and Biogen's subcutaneous starting-dose formulation...

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Alnylam Pharma’s Web Promo is Misleading: FDA

FDA sends an untitled letter to Alnylam Pharmaceuticals, citing misleading promotional claims on a c...

Human Drugs

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3 Observations in STAQ Pharma Inspection

FDA releases the Form FDA-483 with three observations from its inspection at the Columbus, OH-based ...

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Improve ‘Substantial Effectiveness’ Draft Guidance: Stakeholders

Four major stakeholders give numerous suggestions for significantly changing or improving an FDA dra...

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Proteomic Biomarker Framework to Speed Drug Development

An FDA online post explains the benefits of CDER scientists’ work in proteomics-based biomarker disc...

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FDA Accepts Wearable Sensor-Based Foot Drop Measure for Trials

FDA accepts a letter of intent for a wearable sensor-based digital outcome measure designed to asses...

Marketing

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Ardelyx Uses DTC Crackdown Lessons to Shape Ibsrela TV Ad

Ardelyx says it incorporated lessons from FDA's recent prescription drug advertising enforcement act...

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FDA Hits Alar Pharmaceuticals Experimental Ketamine Promotion

FDA issues Alar Pharmaceuticals an untitled letter over promotional materials for its investigationa...

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FDA Promotion Crackdown Enters New Phase: Attorneys

Attorneys from Arnall Golden Gregory examine and offer advice on FDA’s intensified scrutiny of drug ...

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FDA Plan Would ‘Fundamentally Reshape’ Drug Ads

Two Sheppard attorneys say an FDA proposal to require complete safety and risk information within th...

Medical Devices

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Multiple Types of Violations at Specialty Health Products

FDA warns Phoenix, AZ-based Specialty Health Products about multiple violations in its marketing of ...

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FDA Panel Backs Grail's Galleri Multi-Cancer Blood Test

An FDA advisory committee votes Wednesday to recommend approval of Grail's Galleri multi-cancer earl...

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FDA Panel Backs Grail's Galleri Multi-Cancer Blood Test

An FDA advisory committee votes Wednesday to recommend approval of Grail's Galleri multi-cancer earl...

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Petition Seeks FDA Probe of Intuitive Surgical's da Vinci Device

A citizen petition seeks a safety investigation and potential recall of Intuitive Surgical's da Vinc...