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Supply Chain Changes Needed to Ease Drug Shortages: FDA

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An FDA annual report to Congress on drug shortages in 2021 identifies two supply chain needs that must be worked on.

Reform Paragraph 4 Certification Process: Analysis

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A Health Affairs analysis from West Health Policy Center suggests two reforms for the Waxman-Hatch Paragraph 4 process that could ...

Draeger Recalls SafeStar 55 Breathing Filter

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Draeger recalls (Class 1) one lot of its SafeStar 55 Breathing System Filter because a manual inspection process revealed that som...

Paratek Pharma Fast Track for Nuzyra

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FDA grants Paratek Pharmaceuticals a fast track designation for an oral and intravenous formulation of its broad-spectrum antibiot...

FDA Authorizes Covid Vaccine in Young Children

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FDA authorizes Modernas Covid-19 vaccine and Pfizer-BioNTechs Covid-19 vaccine for use in children as young as six months of age. ...

Info Collection on Biologic Deviation Reporting

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Federal Register notice: FDA seeks comments on an information collection extension entitled Biological Products: Reporting of Biol...

FTC Targets Drug Rebate Schemes Affecting Formularies

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The Federal Trade Commission says it is ratcheting up enforcement against any illegal bribes and rebate schemes that give drugs pr...

FDA Posts 3 Nanotechnology Standards for Liposomes

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FDAs National Center for Toxicological Research announces the publication of three International Test Method Standards in Nanotech...

Drug Compounding Information Collection Revision

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Federal Register notice: FDA seeks comments on an information collection revision entitled Human Drug Compounding Under Sections 5...

Info Collection on Influenza A Reagents Guide

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Federal Register notice: FDA sends to OMB an information collection extension entitled Guidance on Reagents for Detection of Speci...