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FDA warns about adverse event reports it has received that may be related to overdoses due to dosing errors associated with compounded semaglutide injectable products.

latest-news

FDA issues a clinical hold on a vTv Therapeutics Phase 3 trial (CATT1) involving cadisegliatin (XXX DE-ITALICIZE XXX)and its use in improving glycemic control in Type 1 diabetes patients.

LATEST NEWS

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Alert on Compounded Semaglutide Overdoses

FDA warns about adverse event reports it has received that may be related to overdoses due to dosing errors associated with compounded semaglutide injectable products.

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FDA Slaps Hold on Diabetes Investigational Drug

FDA issues a clinical hold on a vTv Therapeutics Phase 3 trial (CATT1) involving cadisegliatin (XXX DE-ITALICIZE XXX)and its use in improving glycemic control in Type 1 diabetes patients.

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Blog Post on Device AI Lifecycle Model

A new CDRH blog post outlines key activities that should be taking place during the lifecycle of artificial intelligence-enabled medical devices.

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Sun’s JAK Inhibitor OK’d for Alopecia Areata

FDA approves a Sun Pharmaceutical Industries NDA for Leqselvi (deuruxolitinib) 8 mg tablets for treating adults with severe alopecia areata.

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Animal Drugs

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medical-devices
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VICH Residual Solvents Guidance

FDA publishes a Veterinary International Conference on Harmonization revised guidance on residual solvents used in animal drugs.

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.

Biologics

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medical-devices
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Covid-19 Convalescent Plasma Guidance

FDA publishes an immediately effective guidance with its recommendations for investigational and licensed Covid-19 convalescent plasma.

medical-devices
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Recommend Transition to HTS Technology: MIT Letter

Two stakeholders call for changes to an FDA draft guidance on safety testing of human allogeneic cells expanded for use in cell-based medical products...

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...

FDA General

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medical-devices
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House FDA Budget Bill Floor Vote Scrapped

House Republican leaders postpone a floor vote this week on FDA’s fiscal year 2025 budget.

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.

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Federal Register

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Pulmonary-Allergy Drugs Panel Renewal

Federal Register notice: FDA announces the renewal for two years of its Pulmonary-Allergy Drugs Advi...

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Pediatric Committee to Mull Safety of 41 Products

Federal Register notice: FDA announces a 9/18 Pediatric Advisory Committee meeting that will discuss...

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Guide on e-Health Records to Support Submissions

Federal Register notice: FDA makes available a final guidance entitled ‘‘Real-World Data: Assessing ...

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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...

Human Drugs

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Alert on Compounded Semaglutide Overdoses

FDA warns about adverse event reports it has received that may be related to overdoses due to dosing...

motusgi
Read More
FDA Slaps Hold on Diabetes Investigational Drug

FDA issues a clinical hold on a vTv Therapeutics Phase 3 trial (CATT1) involving cadisegliatin (XXX ...

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Read More
Sun’s JAK Inhibitor OK’d for Alopecia Areata

FDA approves a Sun Pharmaceutical Industries NDA for Leqselvi (deuruxolitinib) 8 mg tablets for trea...

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Brassica Pharma Hit with 10-item FDA-483

A January inspection of Brassica Pharma’s Indian sterile drug manufacturing facility leads to a 10-o...

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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Blog Post on Device AI Lifecycle Model

A new CDRH blog post outlines key activities that should be taking place during the lifecycle of art...

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bioMérieux Respiratory/Sore Throat Panel Cleared

FDA clears a bioMérieux 510(k) for its Biofire Spotfire Respiratory/Sore Throat Panel Mini for detec...

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Medtronic Recalls NIM Vital Nerve Monitor

Medtronic’s Xomed unit recalls (Class 1) its NIM Vital Nerve Monitoring system due to the potential ...

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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...