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A citizen petition seeks a safety investigation and potential recall of Intuitive Surgical's da Vinci Permanent Cautery Spatula, citing reports of mechanical and electrical component failures and a recent recall involving a related robotic surgical instrument.

latest-news

FDA Matters blog author Steven Grossman urges the Senate HELP Committee to examine how FDA commissioner-nominee Heidi Overton intends to make regulatory decisions, including her commitment to scientific evidence, transparency and established agency procedures.

LATEST NEWS

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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 Vinci Permanent Cautery Spatula, citing reports of mechanical and electrical component failures and a recent recall involving a related robotic surgical instrument.

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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 regulatory decisions, including her commitment to scientific evidence, transparency and established agency procedures.

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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 tovecimig for treating previously treated, advanced biliary tract cancer.

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FDA: Empower Pharmacy Illegally Compounding GLP-1s

FDA warns Houston, TX-based Empower Pharmacy that it is illegally compounding GLP-1 drugs under conditions that violate CGMP regulations.

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Animal Drugs

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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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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.

medical-devices
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Ultragenyx Gains Approval for Resubmitted Gene Therapy

FDA approves Ultragenyx Pharmaceutical’s Fayuvi (rebisufligene etisparvovec-hopf), the first treatment for pediatric patients with Sanfilippo syndrome...

medical-devices
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FDA Clears Path for Rocket to Complete Pivotal Gene Therapy Trial

FDA agrees to key elements of Rocket Pharmaceuticals’ modified pivotal Phase 2 trial of RP-A501 for Danon disease, allowing the company to continue en...

FDA General

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medical-devices
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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...

medical-devices
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FDA EDDO Control Strategy Guidance Analyzed

Staff from FDA and several drug companies use a Journal of Regulatory Affairs article to explain a 2024 FDA guidance on optimizing EDDO control strate...

medical-devices
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Kennedy Vaccine Remarks Raise Stakes for Overton Confirmation Hearing

HHS secretary Robert F. Kennedy Jr.'s vaccine skepticism remarks this week likely complicate Heidi Overton’s upcoming confirmation hearing to lead FDA...

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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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FDA: Empower Pharmacy Illegally Compounding GLP-1s

FDA warns Houston, TX-based Empower Pharmacy that it is illegally compounding GLP-1 drugs under cond...

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CGMP Violations at kdc/one Chatsworth

FDA warns Chatsworth, CA-based kdc/one Chatsworth about CGMP violations in its production of finishe...

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Drug Groups Seek Changes to FDA's Distributed Manufacturing Rule

Three major pharmaceutical industry associations urge FDA to revise its proposed distributed manufac...

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Insmed sNDA Gets Priority Review for Arikayce Full Approval

FDA accepts for priority review an Insmed supplemental NDA seeking traditional approval for Arikayce...

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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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...

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Study: AI-Assisted Device Reviews Could Reduce Recalls

A new study finds that a machine learning-based approach to FDA's 510(k) medical device clearance pr...

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FDA Seeks Advisory Panel Input on Galleri Cancer Screening Test

FDA seeks advisory committee input on the benefits and risks of GRAIL's Galleri multi-cancer early d...

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FDA Identifies CooperSurgical Infant Nasal CPAP Recall as Class 1

FDA classifies as Class 1 a CooperSurgical recall of certain INCA Infant Nasal CPAP Complete Sets an...