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Abrams Recalls Sterile Compounded Products

[ Price : $8.95]

Abrams Royal Pharmacy recalls all unexpired lots of its sterile compounded products due to a lack of sterility assurance.

FDA Clears Royal Phillips Breast Density App

[ Price : $8.95]

FDA clears a Royal Philips 510(k) for the Spectral Breast Density Measurement Application for its MicroDose SI full-field digital ...

Morrison Promoted to ORA Operations Assistant Commissioner

[ Price : $8.95]

FDA Office of Commissioner crisis management director Ellen Morrison moves up to Office of Regulatory Affairs assistant commission...

Alimera Talking with FDA on Iluvien Labeling

[ Price : $8.95]

FDA says it is working with Alimera on Iluvien labeling and there is no need for the company to participate in an upcoming advisor...

Comments Sought on Supplement GMP Info

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Federal Register Notice: FDA seeks comments on information collection provisions in FDAs CGMP regulations for dietary supplements....

Comments Sought on Tobacco Substantial Equivalence Requirements

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Federal Register Notice: FDA seeks comments on a proposed collection of information on exemptions from substantial equivalence req...

OMB OKs Info on Device ID

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Federal Register Notice: The Office of Management and Budget approves a collection of information entitled Unique Device Identific...

OMB OKs Info on Cardiovascular Labeling

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Federal Register Notice: The Office of Management and Budget approves a collection of information on a guidance on hypertension in...

Petition Cant Trigger FDA Enforcement Action

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FDA denies Eclats petition to have unapproved neostigmine methylsulfate injectable products removed from the market because petiti...

UDI Expert Crowley Retires to Join Industry

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CDRH patient safety senior advisor Jay Crowley retires from FDA to join regulatory consulting firm USDM Life Sciences as vice pres...