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FDA publishes a draft guidance to help with animal studies for dental bone grafting devices submitted with a 510(k).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 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FDA publishes a draft guidance to help with animal studies for dental bone grafting devices submitted with a 510(k).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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3-year-old Fusion IV FDA-483 Released

FDA releases the form FDA-483 that was issued following a 2019 inspection at the Fusion IV outsourcing facility in Los Angeles, CA.

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FDA releases a draft guidance entitled “Manufacture of Batches in Support of Original NADAs, ANADAs, and CNADAs.”

medical-devices
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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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Medexus’ Hemophilia B Factor Gets Expanded Use

FDA approves a Medexus Pharmaceuticals supplemental BLA for Ixinity [coagulation factor IX (recombinant)] for treating pediatric patients under 12 yea...

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...

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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FDA Withdraws 30 No-Longer-Marketed ANDAs

Federal Register notice: FDA withdraws approval of 30 abbreviated new drug applications from multipl...

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OTC Monograph Drug User Fees

Federal Register notice: FDA announces the over-the-counter Monograph Drug User Fee Program facility...

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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...

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.

motusgi
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
3-year-old Fusion IV FDA-483 Released

FDA releases the form FDA-483 that was issued following a 2019 inspection at the Fusion IV outsourci...

motusgi
Read More
Amneal Recalls 4 Lots of Vancomycin

FDA says Amneal is recalling four lots of vancomycin HCl for oral solution because some of the bottl...

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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ASCA Pilot Met, Exceeded Expectations: CDRH

The CDRH Accreditation Scheme for Conformity Assessment pilot final report says the effort met and s...

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Synaptive Medical Fluorescence Module Cleared

FDA clears a Synaptive Medical 510(k) for its near-infrared fluorescence visualization module, Modus...

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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 ...