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TXT Draft Guide on Quality Risk Management [105 Words] [ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance for industry entitled “Q9(R1) Quality Risk Management (QRM).”
06/15/2022
 
 
TXT CDER’s Cavazzoni Spearheading Rare Disease Program [842 Words] [ Price : $8.95]
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.
06/15/2022
 
 
TXT Regenerative Medicine Consensus Standard Guidance [2679 Words] [ Price : $8.95]
FDA publishes a draft guidance on the voluntary consensus standards recognition program for regenerative medicine therapies.
06/15/2022
 
 
TXT Panel Backs Pfizer, Moderna Covid Vaccines in Young Kids [203 Words] [ Price : $8.95]
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.
06/15/2022
 
 
TXT Quantitative Imaging Assessment in Premarket Submissions [2677 Words] [ Price : $8.95]
FDA publishes a guidance with recommendations for manufacturers on information to go in premarket submissions for radiological devices with quantitative imaging functions.
06/15/2022
 
 
TXT Alliance Supports FDA Funding Bill [2709 Words] [ Price : $8.95]
The Alliance for a Stronger FDA says it supports the FDA funding proposed by a House Agriculture Appropriations subcommittee.
06/15/2022
 
 
TXT Generic Drug Covid-19 Successes Touted [168 Words] [ Price : $8.95]
CDER director Patrizia Cavazzoni praises accomplishments in the generic drug program during Covid-19.
06/15/2022
 
 
TXT Make Oral Contraceptives OTC: AMA [143 Words] [ Price : $8.95]
The American Medical Association calls on FDA to approve a switch of hormonal oral contraceptives from prescription to over-the-counter status.
06/15/2022
 
 
TXT FDA Update on Heater-Cooler Devices [143 Words] [ Price : $8.95]
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.
06/14/2022
 
 
TXT ‘Objectionable Conditions’ in 2 Clinical Trials [253 Words] [ Price : $8.95]
FDA warns Smitha Reddy and her Poway, CA-based ACRC Studies facility about objectionable conditions in conducting two clinical investigations.
06/14/2022
 
 
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