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After receiving a 2019 complete response letter, Lexicon Pharmaceuticals resubmits its NDA for sotagliflozin oral tablets as an adjunct to insulin therapy in patients with Type 1 diabetes and chronic kidney disease.

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CBER director Peter Marks again overrides his Center’s review teams in approving a supplemental BLA that expands the approval and converts to full approval Sarepta Therapeutics’ Duchenne muscular dystrophy gene therapy Elevidys.

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Lexicon Refiles NDA for Sotagliflozin

After receiving a 2019 complete response letter, Lexicon Pharmaceuticals resubmits its NDA for sotagliflozin oral tablets as an adjunct to insulin therapy in patients with Type 1 diabetes and chronic kidney disease.

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Déjà vu: Marks Overrides Reviewers on Duchenne Drug Again

CBER director Peter Marks again overrides his Center’s review teams in approving a supplemental BLA that expands the approval and converts to full approval Sarepta Therapeutics’ Duchenne muscular dystrophy gene therapy Elevidys.

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Zoll Recalls Ventilators Over Operator Guides

Zoll Medical recalls (Class 1) its Zoll 731 Ventilators and their operator and quick reference guides.

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Switching Studies for Interchangeable Biosimilars Guide

Federal Register notice: FDA makes available a draft guidance entitled “‘Considerations in Demonstrating Interchangeability With a Reference Product: Update.”

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Animal Drugs

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medical-devices
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Human User Safety in Animal Drugs Guidance

FDA publishes a guidance explaining how CVM assesses human user safety in applicable animal drug applications.

medical-devices
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Mass Spectrometry Guide for Animal Drugs

FDA posts a final guidance entitled “Mass Spectrometry for Confirmation of the Identity of Animal Drug Residues.”

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.”

Biologics

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medical-devices
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Déjà vu: Marks Overrides Reviewers on Duchenne Drug Again

CBER director Peter Marks again overrides his Center’s review teams in approving a supplemental BLA that expands the approval and converts to full app...

medical-devices
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FDA Abandoning Biosimilar Switching Studies

FDA issues a draft guidance indicating that it is moving away from recommending switching studies to support an interchangeability determination for b...

medical-devices
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Merck’s Pneumococcal 21-Valent Vaccine Approved

FDA grants Merck accelerated approval for Capvaxive (Pneumococcal 21-valent conjugate vaccine) for preventing invasive disease and pneumonia caused by...

medical-devices
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Novavax Amends Covid Vaccine EUA

Novavax files an amendment to its Emergency Use Authorization for an updated JN.1 Covid-19 vaccine (NVX-CoV2705) for individuals aged 12 and older.

FDA General

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medical-devices
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FDA WEBVIEW CLOSED 6/19 FOR JUNETEENTH

FDA Webview’s newsroom closes Wednesday 6/19 in recognition of the federal holiday Juneteenth.

medical-devices
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Appropriators Slash FDA Budget by $450 Million

A House Appropriations subcommittee slashes $450 million (6%) from FDA’s fiscal year 2025 budget.

medical-devices
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DePuy Synthes Gets 510(k) for Robotic Knee Device

FDA clears a DePuy Synthes 510(k) for the VELYS Robotic-Assisted Solution and its use in unicompartmental knee arthroplasty.

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Office of Regulatory Affairs, Other Changes Approved

FDA says an agency reorganization changing the operation of the Office of Regulatory Affairs is scheduled to take effect 10/1.

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Federal Register

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Switching Studies for Interchangeable Biosimilars Guide

Federal Register notice: FDA makes available a draft guidance entitled “‘Considerations in Demonstra...

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Guide on Adulteration when Inspection Refused

Federal Register notice: FDA makes available a final guidance entitled “Circumstances That Constitut...

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Guide on Human User Safety in Animal Drugs

Federal Register notice: FDA makes available a final guidance entitled “Human User Safety in New and...

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Target Health ANDA Withdrawals Notice Corrected

Federal Register notice: FDA corrects a 3/29 notice on the approval withdrawals of 30 ANDAs from mul...

Human Drugs

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Lexicon Refiles NDA for Sotagliflozin

After receiving a 2019 complete response letter, Lexicon Pharmaceuticals resubmits its NDA for sotag...

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Workshop on NDA/BLA Meeting Management Practices

FDA announces a 7/22 public workshop on “Best Practices for Meeting Management Under PDUFA VII.”

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Lilly’s Files Mounjara NDA for Sleep Apnea

Eli Lilly says it has submitted an NDA for weight loss therapy Mounjaro (tirzepatide) for treating m...

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FDA OKs New Skyrizi Indication

FDA approves a new ulcerative colitis indication for AbbVie’s Skyrizi.

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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Zoll Recalls Ventilators Over Operator Guides

Zoll Medical recalls (Class 1) its Zoll 731 Ventilators and their operator and quick reference guide...

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De Novo for Onkos Implant Antibacterial Coating

FDA grants Onkos Surgical a de novo authorization for its novel antibacterial coating for use with i...

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Elixir Breakthrough Status for Coronary Bioadapter

FDA grants Elixir Medical a Breakthrough Device Designation for its novel bioadaptive implant DynamX...

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Akili OTC App Cleared for ADHD

FDA clears an Akili 510(k) for EndeavorOTC (AKL-T01) as an over-the-counter treatment for adults wit...