April 20, 2021
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Drugs & Biologics
The FDA has asked Emergent BioSolutions to stop manufacturing a new drug substance for Johnson & Johnson's COVID-19 vaccine at its Baltimore plant while the agency investigates a contamination issue that resulted in the destruction of millions of doses last month. J&J said it will work with the agency and Emergent to address any issues uncovered in the investigation.
Full Story: Reuters (4/19) 
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The CDC could decide by Friday if restrictions will be added to the Johnson & Johnson vaccine after six women reported blood clotting issues after receiving the shot, according to National Institute of Allergy and Infectious Diseases Director Anthony Fauci. The US paused use of J&J's vaccines last week.
Full Story: KOMO-TV/KOMO-AM (Seattle) (4/19) 
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CDC: Americans 16 and up can now get COVID-19 vaccine
(Joe Raedle/Getty Images)
All US individuals ages 16 and older can now receive a COVID-19 vaccine, according to the CDC, which said those with underlying medical conditions that raise the risk for serious complications should be given priority. Nearly 211.6 million COVID-19 vaccine doses had been administered in the US as of Monday, with more than 85.3 million people now fully vaccinated.
Full Story: Reuters (4/19),  Reuters (4/20) 
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Medical Devices
The FDA has updated regulations for certain medical devices, including three radiology software products -- picture archiving and communications systems, medical image storage devices and medical image communication devices. The rules are effective immediately.
Full Story: AuntMinnie (free registration) (4/16) 
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The FDA has approved Saige-Q, an AI-based mammography triage software from RadNet's subsidiary DeepHealth. Saige-Q is the first FDA-approved triage product that supports 2D and 3D mammography.
Full Story: Radiology Business (4/19) 
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The FDA has given 510(k) clearance to Canon Medical Systems for its Deep Learning Spectral CT's expanded capabilities for cardiovascular applications.
Full Story: MassDevice (Boston) (4/19) 
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European regulators have given CE mark approval to Contego Medical for its Neuroguard IEP 3-in-1 carotid stent system and post-dilation balloon system with integrated embolic protection.
Full Story: MassDevice (Boston)/Medical Tubing & Extrusion (4/19) 
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European regulators have given CE mark approval to Seigla Medical for its LiquID Guide Catheter Extension, which is used to help deliver stents and other interventional devices.
Full Story: FDAnews (4/20) 
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Food and Drug Law Institute (FDLI) Highlights
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Thursday's Author Happy Hour: Implementing Effective Escalation Processes in Life Sciences Companies | April 22, 5:00 PM EDT | Virtual Event
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Join FDLI at Thursday's virtual "Author Happy Hour" to discuss the Update magazine article, "Going Up the Chain: Escalation of Significant Issues in Life Sciences Companies." Authors will discuss available regulatory guidance related to escalation, how issues are typically escalated, and common challenges to consider when implementing or enhancing escalation processes. Register Now
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