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Medical Devices

Teleflex Recalls Endotracheal Tubes

Teleflex recalls its Slick Set Uncuffed Endotracheal Tube and Stylet Set (oral/nasal) due to reports about the 15mm connector disconnecting from the e...

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Human Drugs

House Bill on Provisional Drug Approvals

Bipartisan House members reintroduce the Promising Pathway Act that would provide a provisional approval pathway for promising drugs.

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Federal Register

Info Collection on New Animal Drugs

Federal Register notice: FDA announces an information collection revision entitled New Animal Drugs for Minor Use and Minor Species.

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Human Drugs

More Regulation Needed for Generics: Bloomberg

A Bloomberg editorial calls for better FDA regulation and more transparency in dealing with generic drugs and active pharmaceutical ingredients coming...

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Federal Register

Guide on Chronic Rhinosinusitis Drugs

Federal Register notice: FDA makes available a final guidance entitled Chronic Rhinosinusitis With Nasal Polyps: Developing Drugs for Treatment.

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Federal Register

8 Information Collections Approved by OMB

Federal Register notice: FDA posts a list of eight information collections that have been approved by OMB.

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Medical Devices

510(k) Filed for LumiraDx Covid Test

LumiraDx files a 510(k) to gain clearance for its five-minute Covid Ultra Test and the LumiraDx Instrument.

Medical Devices

FDA Allows 1st Master File Use for Sterilizer

FDA accepts the first master file for participation in the 510(k) Ethylene Oxide Sterility Change Master File Pilot Program.

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FDA General

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 10.

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Federal Register

Patient Guides for Orthopedic Implants

Federal Register notice: FDA announces the availability of the draft guidance entitled Patient-Matched Guides to Orthopedic Implants.