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Info Collection Extension for Panel Nominations

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension for its Advisory Committee Membership Nominatio...

Incyte Transplant Drug Disappoints in Phase 3

[ Price : $8.95]

Incyte says its pivotal Phase 3 GRAVITAS-301 study evaluating itacitinib in combination with corticosteroids in certain patients w...

Latest Federal Register Notices

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FDA Review posts the Federal Register notices for the week ending 1/3/2020.

Continue Kickback Protection for Drugs, Devices: WLF

[ Price : $8.95]

Washington Legal Foundation calls on the HHS Inspector General to reverse its proposal to exclude drug and medical device manufact...

Info Collection Extension on Special Protocols

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension for its guidance on Special Protocol Assessment...

Cook Medical Recalls CrossCath Catheters

[ Price : $8.95]

Cook Medical recalls its CrossCath Support Catheters due to a manufacturing error which may cause the marker bands to dislodge.

Info Collection on Electronic Imports Revised

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Federal Register notice: FDA seeks comments on an information collection revision for Imports and Electronic Import Entries.

Smiths Recalls Medfusion 4000 Syringe Pumps

[ Price : $8.95]

Smiths Medical recalls its Medfusion 4000 Syringe Pumps due to malfunctioning alarms and potential therapy interruption.

Chembio Expects HIV/Syphilis Approval in 2 Months

[ Price : $8.95]

Chembio Diagnostics says it expects FDA approval in two months on its PMA for the DPP HIV-Syphilis System.

Stakeholders Want CDS Guidance Clarified

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Several stakeholders call on FDA to further clarify and explain its revised draft guidance on clinical decision support software.