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Medical Devices

Draeger Recalls SafeStar 55 Breathing Filter

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

Human Drugs

Paratek Pharma Fast Track for Nuzyra

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

Biologics

FDA Authorizes Covid Vaccine in Young Children

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

Federal Register

Info Collection on Biologic Deviation Reporting

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

Human Drugs

FTC Targets Drug Rebate Schemes Affecting Formularies

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

Human Drugs

FDA Posts 3 Nanotechnology Standards for Liposomes

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

Federal Register

Drug Compounding Information Collection Revision

Federal Register notice: FDA seeks comments on an information collection revision entitled Human Drug Compounding Under Sections 503A and 503B of the ...

Federal Register

Info Collection on Influenza A Reagents Guide

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

Human Drugs

Bill Would Establish FDA/USPTO Patent Task Force

Sens. Dick Durbin (D-IL), chair of the Senate Judiciary Committee, ranking member Chuck Grassley (R-IA) and Thom Tillis (R-NC) introduce bipartisan le...

Medical Devices

Guide on Power Morcellator Containment Systems

CDRH makes available a draft guidance on Power Morcellator containment systems clinical performance assessments.