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In annual observance of the Fourth of July (Independence Day) holiday in the U.S., FDA Webview closes its news operations until Monday, July 7.

latest-news

FDA clears an Atmo Biosciences 510(k) for the ingestible Atmo Gas Capsule System for assessing both whole and regional gut transit times.

LATEST NEWS

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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 7.

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Atmo Bio’s Gut Capsule Cleared by FDA

FDA clears an Atmo Biosciences 510(k) for the ingestible Atmo Gas Capsule System for assessing both whole and regional gut transit times.

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Report Highlights Study Demographic Representation

A new FDA report examines the demographic representation of clinical trials supporting the approval of 50 novel drug therapies last year.

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REMS Requirements Ended for CAR T Cell Therapies

FDA removes risk evaluation and mitigation strategies requirements for all currently approved CAR T cell therapies, saying the programs have burdened prescribers and are no longer necessary to ensure patient safety.

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Animal Drugs

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medical-devices
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Sumitomo Pharma Gets Fast Track Status for Nuvisertib

FDA grants Sumitomo Pharma a fast-track designation for nuvisertib (TP-3654) for treating patients with intermediate or high-risk myelofibrosis.

medical-devices
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Researchers Challenge FDA Lamictal Safety Warning

Rutgers University researchers say they have determined that the GlaxoSmithKline anti-seizure drug Lamictal is safe for adults with epilepsy and conco...

medical-devices
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GSK Plans for Antibiotic NDA in 2nd Half

GSK plans to submit an NDA in the second half of the year after it and Spero Therapeutics announced that they will end their Phase 3 PIVOT-PO clinical...

medical-devices
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Prothena Scraps Birtamimab After Phase 3 Miss

Prothena discontinues the development of birtamimab, its investigational treatment for AL amyloidosis, after the drug failed to meet primary or second...

Biologics

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medical-devices
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Marks: Why ‘Dramatic Departure’ from Vaccine Policy?

Former CBER director Peter Marks says FDA should explain why it changed its Covid-19 vaccine policy in a way that did not promote transparency and gol...

medical-devices
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FDA Approves New Warnings on Covid mRNA Vaccines

FDA requires and approves updates to the prescribing information for Pfizer’s Comirnaty Covid-19 mRNA vaccine and Moderna’s Spikevax Covid-19 mRNA vac...

medical-devices
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FDA Skips Panel Review for Capricor Cell Therapy

FDA says there will be no advisory committee review of Capricor Therapeutics BLA for Deramiocel, the company’s lead cell therapy candidate for treatin...

medical-devices
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FDA Halts Some Cell Clinical Trials

FDA says it is reviewing all clinical trials that rely on a Biden administration exemption that allowed sensitive biological material, including DNA, ...

FDA General

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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 7.

medical-devices
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Reverse FDA Restructuring: Former GOP Representative

Former GOP Rep. John Doolittle calls for immediate steps to reverse some of the FDA restructuring that he says will hurt regulated companies, patients...

medical-devices
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Securing Technology, Equipment Report

The FDA Office of Regulatory and Emerging Science publishes a report describing agency efforts to research cybersecurity and advanced manufacturing is...

medical-devices
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FDA Webview Closed on Juneteenth (6/19)

FDA Webview closes and will not be publishing on 6/19 in recognition of the U.S. federal holiday, Juneteenth.

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Federal Register

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PDUFA Public Meeting for User Fee Reauthorization

Federal Register notice: FDA announces a 7/14 public meeting to discuss proposed recommendations for...

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Generic Drug Fee Program Reauthorization Meeting

Federal Register notice: FDA hosts a 7/11 public meeting on the reauthorization of the Generic Drug ...

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FDA Withdraws and Reissues 2 Guidances

FDA says it is withdrawing two recent final guidances on cell- and tissue-based products and reissui...

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CDER Continues Quality Management Program

Federal Register notice: FDA seeks drug manufacturing establishments to participate in the second ye...

Human Drugs

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Report Highlights Study Demographic Representation

A new FDA report examines the demographic representation of clinical trials supporting the approval ...

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REMS Requirements Ended for CAR T Cell Therapies

FDA removes risk evaluation and mitigation strategies requirements for all currently approved CAR T ...

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UCB Positive Data for Epileptic Encephalopathy Drug

UCB reports positive data from a Phase 3 clinical trial evaluating fenfluramine as an adjunctive tre...

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Appeals Court Backs FDA’s Sameness Interpretation

An appeals court rules for FDA that a “clinically superior drug is not the same as a drug that is ot...

Marketing

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DTC Ads Kennedy’s Next Target?

Bloomberg News says President Trump and HHS secretary Kennedy are looking at policies that they hope...

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Senators Introduce Bill to Ban DTC Drug Advertising

Senators Bernie Sanders (I-VT) and Angus King (I-ME) introduce legislation that would ban direct-to-...

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Attorney Warns: FDA Watching Professional Promotion

Attorney Nathan Downing says medical product companies should review their professional promotions a...

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RFK Jr. Attacks ‘Corrupt’ Drug Firms and DTC Ads

In a 5/27 podcast interview, HHS secretary Robert F. Kennedy Jr. continues his verbal assault agains...

Medical Devices

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Atmo Bio’s Gut Capsule Cleared by FDA

FDA clears an Atmo Biosciences 510(k) for the ingestible Atmo Gas Capsule System for assessing both ...

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UDI Requirements for Combo Products Guide

FDA posts a draft guidance entitled “Unique Device Identifier (UDI) Requirements for Combination Pro...

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Device Cybersecurity Quality System Consideration Guide

FDA posts a final guidance entitled “Cybersecurity in Medical Devices: Quality System Considerations...

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InspireMD PMA Approved for Carotid Stent

FDA approves an InspireMD PMA for its CGuard Prime Carotid Stent System for treating carotid artery ...