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Promotional Labeling and Advertising Considerations for Prescription B

Guidance for Industry Advertising

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Your Digital Health Regulation Questions Answered - Healthcare

The U.S. Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) regulates medical devices, including software-as-a-medical-device (SaMD).

Digital-health-policy-navigator , Office-of-the-national-coordinator , Office-of-combination-products , Office-for-civil-rights , Digital-health-frequently-asked-questions , Health-app-interactive-tool , Health-breach-notification-rule , Drug-administration , Radiological-health , What-you-need , Health-policy-navigator

New FDA Guidance on AI and Medical Products | Troutman Pepper

New FDA Guidance on AI and Medical Products | Troutman Pepper
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FDA Charts Course for Regulating AI Used in Medical Products | McDermott Will & Emery

On March 15, 2024, four of the US Food and Drug Administration’s (FDA) medical products centers released a joint paper, titled “Artificial Intelligence & Medical Products: How CBER,...

Drug-administration , Office-of-combination-products , Development-of-standards , Radiological-health , Us-congress , Centers-point , Foster-collaboration-to-safeguard-public-health , Development-of-regulatory-approaches-that-support-innovation , Mcdermott-will , Medical-products , Working-together

FDA's Richard Pazdur explains confirmatory trial rejection, more

FDA's Richard Pazdur explains confirmatory trial rejection, more
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Your Digital Health Regulation Questions Answered | Fenwick & West LLP

regulators. The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) regulates medical devices, including software-as-a-medical-device (SaMD)....

Digital-health-policy-navigator , Digital-health-frequently-asked-questions , Radiological-health , Drug-administration , Office-of-the-national-coordinator , Health-app-interactive-tool , Health-breach-notification-rule , Fenwick-west , Office-of-combination-products , Office-for-civil-rights , Health-policy-navigator

Form 20-F Achilles Therapeutics For: Dec 31

Form 20-F Achilles Therapeutics For: Dec 31
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FOIA Documents Reveal How 2 FDA Vaccine Oversight Staffers Sought Employment With Moderna

FOIA Documents Reveal How 2 FDA Vaccine Oversight Staffers Sought Employment With Moderna
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Worker infected with H5N1 bird flu in Texas after cases found in US dairy cows

The present case is the first involving a direct transmission from bovines to humans and is also the first time cows have shown susceptibility to this virus, surprising influenza virologists.

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VBI Vaccines Presents Encouraging Early Tumor Response Data From Randomized Controlled Phase 2b Study of VBI-1901 in Recurrent Glioblastoma

Data highlighted in oral presentation at World Vaccine Congress 2024 on April 3, 2024



Early data from patients eligible for evaluation at week 12 show two observations of stable disease,...

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