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CDRH director Jeff Shuren says he is retiring later this year and deputy Center director for transformation Michelle Tarver will serve as acting director.

latest-news

Attorney Julie Tibbets reviews the Warning Letters issued in FY 2023 and so far in FY 2024 under the FDA Bioresearch Monitoring program.

LATEST NEWS

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Shuren Retiring; Tarver is Acting CDRH Director

CDRH director Jeff Shuren says he is retiring later this year and deputy Center director for transformation Michelle Tarver will serve as acting director.

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Common BIMO Violations Listed

Attorney Julie Tibbets reviews the Warning Letters issued in FY 2023 and so far in FY 2024 under the FDA Bioresearch Monitoring program.

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RWD in Regulatory Decisions Guidance

FDA publishes a guidance on assessing types of medical records to provide real-world data (RWD) for drugs and biologics regulatory decision-making.

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Biocon Biosphere FDA-483

FDA releases the form FDA-483 with three observations from an inspection at Biocon Biosphere in Andhra Pradesh, India.

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Animal Drugs

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medical-devices
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Dog Heartworm Prevention Drug Guidance

FDA publishes a guidance with additional details on earlier guidances on evaluating the effectiveness of drugs indicated to treat heartworm in dogs.

medical-devices
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PZAD Designation, Review Process Guidance

FDA publishes a guidance to help sponsors pursue Priority Zoonotic Animal Drug designation for a new animal drug.

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.”

Biologics

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medical-devices
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FDA Seeks Input on Biosimilar Guidance Development

FDA establishes a docket to receive information and comments on how best to advance the development of new biosimilar biological products through guid...

medical-devices
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Genentech sBLA for Susvimo Accepted for Review

FDA accepts a Genentech supplemental BLA for Susvimo (ranibizumab injection) 100 mg/mL, indicated for treating diabetic macular edema and diabetic ret...

medical-devices
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Panel Input on Need for New Imfinzi Trial: FDA

FDA plans to ask an advisory committee 7/25 whether a new trial should be conducted before approving an AstraZeneca supplemental BLA for Imfinzi (durv...

medical-devices
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Samsung's Soliris Biosimilar Approved

FDA approves a Samsung Bioepis BLA for Epysqli (eculizumab-aagh) as a biosimilar to Alexion’s Soliris (eculizumab), indicated for treating patients wi...

FDA General

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medical-devices
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Almost 3,000 Establishment Inspections in FY 2023

The FDA FY 2023 drug and medical device establishment inspection report lists registered establishments and inspections by type and world region.

medical-devices
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Senate Gives FDA $170 Million Boost for FY 2025

The Senate Appropriations Committee marks up and approves FDA’s fiscal year (FY) 2025 budget, providing a $170 million (2.5%) boost over the FY 2024 s...

medical-devices
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FDA WEBVIEW CLOSED JULY 4TH WEEK

In annual observance of the Fourth of July (Independence Day) holiday in the U.S., FDA Webview closes its news operations until Monday, July 8.

medical-devices
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FDA Opening Office in Rwanda

FDA associate commissioner for global policy and strategy Mark Abdoo says the agency will support the African Medicines Agency through a new office in...

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Federal Register

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Mesa Bio Covid Test Authorization Revoked

Federal Register notice: FDA announces that it revoked a Mesa Biotech emergency use authorization fo...

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Comment Period Extended on FDA IT Strategy

Federal Register notice: FDA extends the comment period on its 6/26-released “Information Technology...

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OMB OKs Quantitative Claims Survey for DTC Ads

Federal Register notice: FDA announces that OMB has approved an information collection entitled “Sur...

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FDA Corrects Xenpozyme Patent Notice

Federal Register notice: FDA corrects a 7/2 notice that announced the determination of the regulator...

Human Drugs

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RWD in Regulatory Decisions Guidance

FDA publishes a guidance on assessing types of medical records to provide real-world data (RWD) for ...

motusgi
Read More
Biocon Biosphere FDA-483

FDA releases the form FDA-483 with three observations from an inspection at Biocon Biosphere in Andh...

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FDA Denies Novartis Entresto Petition

FDA denies a Novartis 2022 petition seeking specific agency actions on ANDAs citing Entresto as the ...

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Pfizer Optimistic on Hemphilia A Gene Therapy

Pfizer plans to discuss with FDA its path to seek approval of its investigational gene therapy for t...

Marketing

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DTC Ad Study Finds Benefit/Risk Conflation

New studies by FDA drug promotion staff find that consumers conflated a drug’s benefits and risks wh...

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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 ...

Medical Devices

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Shuren Retiring; Tarver is Acting CDRH Director

CDRH director Jeff Shuren says he is retiring later this year and deputy Center director for transfo...

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Input on Non-Device Software Functions

Three stakeholders provide requested input to FDA on the risks and benefits of non-device software f...

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QS Issues in Criticare Inspection

FDA warns Criticare Technologies about QS violations in its manufacturing of patient monitors at a m...

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FDA Posts Laboratory-Developed Test FAQs

FDA posts answers to frequently asked questions about its new laboratory-developed test final rule.