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Latest Federal Register Notices

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FDA Review posts the Federal Register notices for the week ending 9/17/2021.

FDA OKs Neovasc IDE for Reducer Device Trial

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FDA approves a Neovasc IDE for its COSIRA-II IDE clinical trial that will evaluate the Reducer device and its use in treating cert...

Panel Backs Limited Covid Booster Shots

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An FDA advisory committee unanimously votes to recommend Pfizer-BioNTechs Comirnaty Covid-19 booster vaccine in individuals 65 yea...

Q & A Guide on Biosimilar Development

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Federal Register notice: FDA makes available a final guidance entitled Questions and Answers on Biosimilar Development and the BPC...

Pfizer Expands Chantix Recall to Include All Lots

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Pfizer expands its Chantix (varenicline) recall to include all lots of 0.5 mg and 1 mg tablets because of the potential presence o...

FDA Safety Alert on Greenpark Compounded Drugs

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An FDA safety alert warns healthcare professionals and patients not to use compounded products from Prescription Labs, doing busin...

Consent Decree Against Florida Drug Outsourcer

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A Florida federal court enters a consent decree against Premier Pharmacy Labs that prohibits it from producing or distributing any...

FDA Clinical Hold on Protagonist Rusfertide Studies

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FDA places a clinical hold against three Protagonist Therapeutics clinical studies for rusfertide due to concerning mouse study fi...

Clozapine REMS Changes Effective 11/15

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FDA says changes to the clozapine REMS to ensure that the drugs benefits outweigh the risk of severe neutropenia take effect 11/15...

Moderna Says Data Support Booster Shot

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Moderna says an analysis of a Phase 3 study of its Covid-19 mRNA vaccine supports the usefulness of a booster shot.