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TXT GDUFA Science and Research Priority Initiatives [2685 Words] [ Price : $8.95]
FDA publishes 15 GDUFA scientific and research priorities for FY 2022.
12/01/2021
 
 
TXT CTI BioPharma Myelofibrosis NDA Review Extended [300 Words] [ Price : $8.95]
FDA extends by three months its review of a CTI BioPharma NDA for treating adult patients with intermediate or high-risk primary or secondary myelofibrosis.
12/01/2021
 
 
TXT FDA Lifts Entolimod Clinical Hold [2657 Words] [ Price : $8.95]
FDA lifts its clinical hold on Statera Biopharma’s entolimod for treating acute radiation syndrome.
12/01/2021
 
 
TXT FDA Updates Cybersecurity Information [2668 Words] [ Price : $8.95]
FDA adds four items to its online medical device cybersecurity page.
12/01/2021
 
 
TXT FDA Monitoring NuVasive Device Concerns [2700 Words] [ Price : $8.95]
FDA says the benefits of NuInvasive titanium-based Precice devices continue to outweigh the known risks with updated labeling in place.
12/01/2021
 
 
TXT Immunexpress Rapid Sepsis Diagnostic Cleared [219 Words] [ Price : $8.95]
FDA clears an Immunexpress 510(k) for its SeptiCyte Rapid, a diagnostic aid for use in differentiating sepsis from infection-negative systemic inflammation in hospitalized patients suspected of sepsis.
12/01/2021
 
 
TXT FDA Puts Clinical Hold on Ocugen Covid Vaccine [245 Words] [ Price : $8.95]
FDA issues a clinical hold for undisclosed reasons on an Ocugen IND intended to evaluate the company’s Covid-19 vaccine candidate, BBV152, which is known as Covaxin outside the U.S.
11/30/2021
 
 
TXT Concerns About FDA Drug/Device Reclassifications Aired [3071 Words] [ Price : $8.95]
Stakeholders express concerns about an FDA decision in response to an appeals court ruling to reclassify some drugs as drug-led combination products.
11/30/2021
 
 
TXT QS Violations at Invacare Facilities [2821 Words] [ Price : $8.95]
FDA warns Invacare about QS violations found in inspections at three of its oxygen concentrator manufacturing facilities.
11/30/2021
 
 
TXT Suggestions for Investigator Safety Reporting Guidance [2674 Words] [ Price : $8.95]
Two stakeholders make suggestions for changes to an FDA draft guidance on investigator responsibility for safety reporting for investigational drugs and medical devices.
11/30/2021
 
 
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