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TXT Real-World Data Guidance on Using Registries [592 Words] [ Price : $8.95]
FDA posts a draft guidance on Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products.
11/29/2021
 
 
TXT Hyperfine MRI Image Reconstruction Cleared [98 Words] [ Price : $8.95]
FDA clears a Hyperfine 510(k) for its advanced image reconstruction technology that uses deep learning to improve magnetic resonance imaging (MRI) on its Swoop MRI device.
11/29/2021
 
 
TXT Imaging Drug OK’d for Ovarian Cancer Detection [268 Words] [ Price : $8.95]
FDA approves an On Target Laboratories NDA for Cytalux (pafolacianine), an imaging drug to assist surgeons in identifying ovarian cancer lesions.
11/29/2021
 
 
TXT Merck’s Covid Drug has 52% Risk Reduction: FDA [428 Words] [ Price : $8.95]
An FDA advisory committee briefing document says Merck’s oral antiviral molnupiravir is associated with a relative risk reduction of 52% in hospitalization or death compared to placebo in adults with mild-to-moderate Covid-19.
11/29/2021
 
 
TXT Regulatory Review Period for Immunomedics’ Trodelvy [98 Words] [ Price : $8.95]
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Immunomedics’ breast cancer therapy Trodelvy.
11/24/2021
 
 
TXT MDR and QS Violations at Smiths Medical [2953 Words] [ Price : $8.95]
FDA warns Minneapolis-based Smiths Medical about Medical Device Reporting and Quality System violations in its work as a specification developer and manufacturer of medical devices.
11/24/2021
 
 
TXT De Novo Classification Rule Webinar [2657 Words] [ Price : $8.95]
FDA schedules a 12/14 Webinar on the medical device de novo classification process and its guidance document updates.
11/24/2021
 
 
TXT Feds Say Frenchman Made False Statements to FDA [2777 Words] [ Price : $8.95]
The Justice Department says a French national has been charged with making false statements to FDA to fraudulently obtain control of the weight-loss drug Sanorex.
11/24/2021
 
 
TXT Pear Therapeutics Breakthrough for Alcohol-use App [139 Words] [ Price : $8.95]
FDA grants Pear Therapeutics a breakthrough device designation for its reSET-A PDT (Prescription Digital Therapeutic) product candidate designed for treating alcohol use disorder.
11/24/2021
 
 
TXT Multiple Violations Found in Surgenex Inspection [2997 Words] [ Price : $8.95]
FDA warns Scottsdale, AZ-based Surgenex about CGMP and other violations in its production and distribution of cellular products for allogenic use.
11/24/2021
 
 
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