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CDER Approved 50 New Drugs in 2021: Annual Report

[ Price : $8.95]

A CDER drug approval annual report discusses the 50 new therapies approved by the Center in 2021.

Appeals Court Affirms Gilenya Patent Blocking ANDAs

[ Price : $8.95]

The U.S. Federal Circuit Court of Appeals upholds a lower court decision that found valid a Novartis patent covering a dosing regi...

N-Lorem Foundation Praises FDA ASO Guidance

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n-Lorem Foundation says a new FDA guidance on antisense oligonucleotides will help it develop new treatments for nano-rare patient...

Exceedingly Burdensome: PhRMA to FDA on Reporting Guide

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Pharmaceutical Research and Manufacturers of America tells FDA its draft guidance on reporting the amount of listed drugs and biol...

FDA Petition Answer Nonresponsive: CRN

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The Council for Responsible Nutrition says FDA failed to respond to its legal inquiry on the agencys policy shift involving market...

Multiple Charges Against NC Physician

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The Justice Department says a federal grand jury indictment charges a North Carolina doctor with multiple offenses related to Medi...

FDA Clears VySpan System

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FDA clears the VySpine VySpan posterior cervical thoracic system.

Organization Structures at 4 FDA Centers Modified

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Federal Register notice: FDA announces that CDER, CBER, CDRH and Center for Tobacco Products have modified their organizational st...

FDA Clears Meridian Campylobacter Assay

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FDA clears a Meridian Bioscience 510(k) for the Curian Campy assay, a rapid, qualitative fluorescent immunoassay for detecting Cam...

Revised PhRMA Code Now in Effect

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Attorney Faraz Siddiqui explains provisions of the revised PhRMA Code on company interactions with healthcare practitioners and wh...