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Human Drugs

AstraZeneca Hold Lifted on Covid Vaccine Trial

FDA lifts a clinical hold against AstraZeneca and the University of Oxford to resume clinical trials of their coronavirus vaccine, AZD1222.

Biologics

Covid Travel Ban Blocks Spectrum Cancer Drug Inspection

FDA defers a review action on a Spectrum Pharmaceuticals BLA for Rolontis (eflapegrastim) because of a Covid-19-related travel restriction that preven...

Medical Devices

Medtronic PMA OKd for Abre Venous Stent

FDA approves a Medtronic PMA for its Abre venous self-expanding stent system for use in the iliofemoral veins in patients with outflow obstructions.

Human Drugs

Janssen Files sNDA for Xarelto Plus Aspirin in PAD

Janssen files a supplemental NDA for a new indication to expand Xareltos (rivaroxaban) use in patients with peripheral artery disease.

Human Drugs

FDA/Pharmacy Boards MOU for Compounded Drugs

Federal Register notice: FDA makes available a final standard memorandum of understanding entitled Memorandum of Understanding Addressing Certain Dist...

Federal Register

Latest Federal Register Notices

FDA Review posts the Federal Register notices for the week ending 10/23/2020.

Federal Register

Guide on Drug Distributor Enforcement Delay

Federal Register notice: FDA makes available a final guidance entitled Wholesale Distributor Verification Requirement for Saleable Returned Drug Produ...

Medical Devices

CDRH Seeking Least Info to Declare Standard Conformity

CDRH officials say they are looking to identify the least amount of information that device companies need to support a declaration of conformity to a...

Medical Devices

Seizure Monitor Gets Breakthrough Status

FDA grants Neuro Event Labs a breakthrough device designation for its Nelli, a device designed to automate the identification of seizure events.

Biologics

Health Experts Criticize FDA Covid-19 Vaccine Plan

Several health experts criticize FDAs recent guidance on minimum requirements for Covid-19 vaccines to obtain an emergency use authorization (EUA), sa...