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Three Benesh Friedlander Coplan & Aronoff attorneys say a suit against FDA filed by the Alliance for Natural Health USA could change the way that supplements are marketed.

latest-news

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

LATEST NEWS

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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 Natural Health USA could change the way that supplements are marketed.

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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 outbreak.

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Repeat CGMP Violations Seen in Excelvision Inspection

FDA warns Excelvision about CGMP violations in the production of drugs at its facility in Annonay, France.

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Genzyme Ireland Inspection Documents CGMP Issue

FDA warns Genzyme Ireland about the failure of the firm’s quality control unit to ensure that drugs comply with CGMP requirements.

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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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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.

medical-devices
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Report: Three Finalists Emerge in Next Commissioner Search

Three candidates emerge as finalists to become the next FDA commissioner, according to an Axios report citing sources familiar with the selection proc...

medical-devices
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FDA Policymaking May Return to Normalcy: Former FDAers

Speaking at the BIO 2026 convention, former FDAers criticize the informal way in which agency policy was made and announced under former commissioner ...

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Federal Register

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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...

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PhRMA Urges Changes to FDA’s ‘Plausible Mechanism’ Guidance

PhRMA urges FDA to broaden and clarify its draft guidance on individualized therapies, warning that ...

Human Drugs

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Repeat CGMP Violations Seen in Excelvision Inspection

FDA warns Excelvision about CGMP violations in the production of drugs at its facility in Annonay, F...

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Genzyme Ireland Inspection Documents CGMP Issue

FDA warns Genzyme Ireland about the failure of the firm’s quality control unit to ensure that drugs ...

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FDA Selects 7 PreCheck Pilot Participants

FDA selects seven companies from 80 applications to participate in the agency’s PreCheck Pilot Progr...

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Next-Generation Sequencing Data Submission Guidance

FDA publishes a guidance on submitting next-generation sequencing data to CDER’s Division of Antivir...

Marketing

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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...

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DTC Crackdown Unfazed at Post-Makary FDA: Expert

DTC Perspectives CEO Bob Ehrlich says the sudden departure of former FDA commissioner Marty Makary i...

Medical Devices

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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.

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Insulet Omnipod Pod Recall is Class 1: FDA

FDA says an Insulet recall of specific lots of its Omnipod Pods is Class 1.

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BMC Medical Selling Adulterated, Misbranded CPAPs: FDA

FDA warns China’s BMC Medical that it is marketing adulterated and misbranded ventilators in the U.S...

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Quality System, Other Violations at 3B Medical

FDA warns 3B Medical about multiple violations in its work manufacturing a software device used with...