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FDA publishes a draft guidance to help with animal studies for dental bone grafting devices submitted with a 510(k).

latest-news

FDA approves Akeiba’s Vafseo to treat anemia in some adults with chronic kidney disease.

LATEST NEWS

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Dental Bone Graft Animal Study Guide

FDA publishes a draft guidance to help with animal studies for dental bone grafting devices submitted with a 510(k).

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FDA Approves Akebia Vafseo for Some Anemias

FDA approves Akeiba’s Vafseo to treat anemia in some adults with chronic kidney disease.

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Aldeyra Plans for Reproxalap NDA Resubmission

Aldeyra Therapeutics says it will conduct a dry eye chamber clinical trial of its reproxalap in hopes of resubmitting an NDA for treating dry eye disease.

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2 REMS Assessment MAPPs

CDER publishes two MAPPs on elements of REMS assessments.

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Animal Drugs

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FDA releases a draft guidance entitled “Manufacture of Batches in Support of Original NADAs, ANADAs, and CNADAs.”

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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.

medical-devices
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Animal MUMS Drug Guidance

FDA publishes a guidance to assist sponsors in seeking approval of new animal drugs for minor uses or minor species.

Biologics

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medical-devices
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BIO Suggestions for CGT Potency Guidance

The Biotechnology Innovation Organization suggests ways FDA can improve a draft guidance on potency assurance for cellular and gene therapy products.

medical-devices
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Mesoblast Refiling BLA for Remestemcel-L

Mesoblast says it will refile its BLA for remestemcel-L for treating pediatric steroid-refractory acute graft versus host disease following favorable...

medical-devices
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Regeneron Complete Response on Lymphoma BLA

FDA sends Regeneron Pharmaceuticals two complete response letters on its BLA for odronextamab in relapsed/refractory follicular lymphoma and in R/R di...

medical-devices
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CBER AI/ML Web Page

CBER launches a new Web page on its approach to using AI/ML in regulatory oversight of products it regulates.

FDA General

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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...

medical-devices
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FDA Paper on AI Targets 4 Focus Areas

FDA posts a cross-Center paper entitled “Artificial Intelligence (AI) & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together” that ide...

medical-devices
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FDA Budgets to Expand ‘Foreign Footprint’

FDA associate commissioner for global policy and strategy Mark Abdoo says the agency is requesting funds to begin expanding its foreign operations.

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Federal Register

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Proposed Ban on Certain e-Stimulation Devices

Federal Register proposed rule: FDA proposes to ban electrical stimulation devices intended for self...

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Guidance on Bioequivalence Testing Samples

Federal Register notice: FDA makes available a guidance entitled “Handling and Retention of BA and B...

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Leonowens Debarred for 5 Years

Federal Register notice: FDA issues an order to debar Phillip Leonowens for a period of five years f...

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Clinical Data Interchange Standards Update

Federal Register notice: FDA announces support for the Clinical Data Interchange Standards Consortiu...

Human Drugs

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FDA Approves Akebia Vafseo for Some Anemias

FDA approves Akeiba’s Vafseo to treat anemia in some adults with chronic kidney disease.

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Read More
Aldeyra Plans for Reproxalap NDA Resubmission

Aldeyra Therapeutics says it will conduct a dry eye chamber clinical trial of its reproxalap in hope...

motusgi
Read More
2 REMS Assessment MAPPs

CDER publishes two MAPPs on elements of REMS assessments.

motusgi
Read More
Catalent Indiana FDA-483

FDA releases the form FDA-483 with six observations from an inspection at the Catalent Indiana drug ...

Marketing

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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...

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Industry Faults FDA Research on DTC ‘Implied Claims’

Industry stakeholders question the usefulness and design of proposed CDER Office of Prescription Dru...

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Update FDA Social Media Enforcement: Durbin, Braun

Sens. Durbin and Braun call on FDA to update its prescription ad guidance to reflect the explosion i...

Medical Devices

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Dental Bone Graft Animal Study Guide

FDA publishes a draft guidance to help with animal studies for dental bone grafting devices submitte...

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FDA ‘Fails to Follow Science’ in Electroshock Case: Attorneys

Two attorneys who represented the Canton, MA-based Judge Rotenberg Center in its court case against ...

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Boston Scientific Recalls PolarSheath Steerable

Boston Scientific recalls the PolarSheath Steerable Sheath 12F after the company identified a toolin...

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Magnetic Stimulation for Adolescent Depression Cleared

FDA clears a Neuronetics 510(k) for its NeuroStar Advanced Therapy for use as an adjunct for treatin...