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Draft Guide on Quality Risk Management
[105 Words]
[ Price : $8.95]
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| Federal Register notice: FDA makes available a draft guidance for industry entitled “Q9(R1) Quality Risk Management (QRM).” |
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06/15/2022
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CDER’s Cavazzoni Spearheading Rare Disease Program
[842 Words]
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| CDER director Patrizia Cavazzoni tells FDLI she is personally spearheading the Center’s new rare disease efforts to speed and increase the development of effective and safe treatment options. |
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06/15/2022
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Panel Backs Pfizer, Moderna Covid Vaccines in Young Kids
[203 Words]
[ Price : $8.95]
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| FDA’s Vaccines and Related Biological Products Advisory Committee unanimously votes to recommend the agency expand the Covid-19 emergency use authorizations (EUA) for Pfizer-BioNTech and Moderna to allow their vaccine to be used in children as young as six months of age. |
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06/15/2022
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Alliance Supports FDA Funding Bill
[2709 Words]
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| The Alliance for a Stronger FDA says it supports the FDA funding proposed by a House Agriculture Appropriations subcommittee. |
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06/15/2022
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Make Oral Contraceptives OTC: AMA
[143 Words]
[ Price : $8.95]
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| The American Medical Association calls on FDA to approve a switch of hormonal oral contraceptives from prescription to over-the-counter status. |
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06/15/2022
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FDA Update on Heater-Cooler Devices
[143 Words]
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| FDA provides an update on its ongoing monitoring of heater-cooler devices and the risk of nontuberculous mycobacteria infections in patients who have undergone cardiothoracic surgery using the devices. |
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06/14/2022
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