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Referencing a Stat online report, MSN identifies three finalists to replace Marty Makary as FDA commissioner.

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CDER and CBER continue to experience net workforce losses through the first nine months of fiscal year 2026, although hiring improved during the third quarter, new FDA data show.

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White House Looking at 3 Possible FDA Commissioners: Reports

Referencing a Stat online report, MSN identifies three finalists to replace Marty Makary as FDA commissioner.

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FDA Drug, Biologics Centers Continue Workforce Decline

CDER and CBER continue to experience net workforce losses through the first nine months of fiscal year 2026, although hiring improved during the third quarter, new FDA data show.

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Increase in Drug WLs Shows Structural Problem: Analysis

Krieger Scientific CEO Joseph Morwald says a 59% increase in FDA drug Warning Letters in 2025 over 2024 should be seen by industry as a diagnosis of a structural issue rather than isolated mistakes.

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Hearing on FDA's Role in Retaining Biomedical Innovation in U.S.

A Capitol Hill hearing next week examines how FDA can help strengthen the nation's leadership in biomedical innovation.

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Animal Drugs

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medical-devices
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Petition Urges FDA to Restrict Antibiotic Use in Animals

A coalition of 65 health, environmental, consumer, farming, and animal welfare organizations petition FDA to withdraw approvals for the routine use of...

medical-devices
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FDA Authorizes 1st Generic Animal Drug for New World Screwworm

FDA authorizes Felix Pharmaceuticals’ generic nitenpyram tablets to treat New World screwworm infestations in dogs and cats.

medical-devices
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Open Letter to Trump Urges FDA Push on Rare Diseases

In an opern letter to president Trump, rare disease advocates urge him to push FDA to accelerate approvals for treatments targeting fatal genetic diso...

medical-devices
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FDA Guide on Developing Drugs for Pulmonary Tuberculosis

FDA posts updated guidance outlining how drugmakers should design clinical development programs for new tuberculosis treatments, emphasizing the need ...

Biologics

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medical-devices
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Blood Donor Screening in an Ebola Outbreak

FDA publishes a guidance notifying blood establishments about agency recommendations for screening and deferring blood donors in response to an Ebola ...

medical-devices
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Former CDC Official Alleges Political Interference In Vaccine Policy

During a CBS News interview, former CDC chief medical officer Debra Houry says she left the agency after concluding she could no longer defend its sci...

medical-devices
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FDA Accepts Replimune's Resubmitted BLA for Advanced Melanoma

FDA accepts for review Replimune's BLA resubmission that is seeking accelerated approval of RP1 (vusolimogene oderparepvec) in combination with nivolu...

medical-devices
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EC Opens Antitrust Probe into Sanofi's Flu Vaccine Marketing

The European Commission opens a formal antitrust investigation into whether Sanofi abused its dominant market position by allegedly conducting a misle...

FDA General

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medical-devices
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White House Looking at 3 Possible FDA Commissioners: Reports

Referencing a Stat online report, MSN identifies three finalists to replace Marty Makary as FDA commissioner.

medical-devices
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FDA Plans Rule to Require Full Risk Info in Drug Ads

FDA plans to publish a proposed rule by the end of the year that would require prescription drug advertisements on television, radio and similar broad...

medical-devices
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Insufficient Data on 7 Peptides for Potential Compounding Use: FDA

FDA briefing materials show that agency reviewers have found limited evidence supporting the safety and effectiveness of seven peptide substances that...

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 6.

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Federal Register

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FDA Moves to Cement Complete Response Letter Transparency Policy

FDA looks to formalize one of its most significant transparency initiatives in decades: the public r...

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FDA Warns Brazilian Drug Maker Over Records Request

FDA sends a Warning Letter to Brazilian over-the-counter drug manufacturer Aeroflex Industria de Aer...

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FDA Delays Review Action on Alzheimer’s Drug

FDA delays by three months its decision on Eisai and Biogen's subcutaneous starting-dose formulation...

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Alnylam Pharma’s Web Promo is Misleading: FDA

FDA sends an untitled letter to Alnylam Pharmaceuticals, citing misleading promotional claims on a c...

Human Drugs

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FDA Drug, Biologics Centers Continue Workforce Decline

CDER and CBER continue to experience net workforce losses through the first nine months of fiscal ye...

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Increase in Drug WLs Shows Structural Problem: Analysis

Krieger Scientific CEO Joseph Morwald says a 59% increase in FDA drug Warning Letters in 2025 over 2...

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Read More
Hearing on FDA's Role in Retaining Biomedical Innovation in U.S.

A Capitol Hill hearing next week examines how FDA can help strengthen the nation's leadership in bio...

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Read More
FDA Fast Tracks Arialys’ ART5803

FDA grants Fast Track designation to Arialys Therapeutics’ ART5803 to treat anti-NMDA receptor encep...

Marketing

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FDA Cites Lundbeck Over Vyepti Promotional Claims

FDA sends Lundbeck Seattle Biopharmaceuticals an untitled letter alleging that promotional materials...

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FDA Sued Over Rejection of Supplement Ad Claims

Three Benesh Friedlander Coplan & Aronoff attorneys say a suit against FDA filed by the Alliance for...

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FDA Cites QOL Medical for Misleading Promotion of Sucraid

FDA issues an untitled letter to QOL Medical, alleging that promotional emails for its rare-disease ...

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FDA Drug Ad Crackdown Leads to More Spending on TV/Streaming Ads: Report

An FDA crackdown on allegedly deceptive prescription drug advertising leads to a sharp increase in p...

Medical Devices

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BlephEx 12-Page Warning Letter

FDA warns Brentwood, TN-based BlephEx about multiple violations in its manufacturing of three unappr...

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J&J Wins Approval for Dual-Energy Cardiac Ablation Platform

FDA approves Johnson & Johnson’s Dual Energy Thermocool Smarttouch SF Platform, a catheter ablat...

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MDUFA Performance Goals, Procedures for 2028-2032

FDA releases the draft MDUFA performance goals and procedures approved by CDRH and CBER for the 2027...

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Abiomed Impella Heart Pump Recall is Class 1

FDA says the Abiomed recall of certain Impella CP Sets with SmartAssist is Class 1.