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Medical Devices
US FDA Announces Webinar to Discuss Decentralized Trial Draft Guidance
US FDA recently released the draft guidance on decentralized clinical trials and has also scheduled...
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Medical Devices
Philippines Published News Regarding Guidelines on Regulatory Reliance on t…
The Food and Drug Administration (FDA Philippines) published news regarding guidelines about relying on the...
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Medical Devices
US FDA Proposed Draft Guidance on DCT for Drugs, Biological Products, and D…
The U.S. Food and Drug Administration (FDA) proposed draft guidance that contains its recommendations for...
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Medical Devices
Taiwan Proposed to Use Electronic Manuals Replacing Chinese Manuals for Med…
Taiwan FDA published new law on Electronic Manuals replacing Chinese Manuals for Medical Devices. ...
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Medical Devices
US FDA: Patient-Focused Drug Development: Incorporating Clinical Outcome As…
US FDA proposed draft guidance titled “Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints...
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Medical Devices
US FDA Proposed Draft Guidance on Premarket Submissions for Orthopedic Non-…
The U.S. Food and Drug Administration (FDA) proposed a draft guidance document that provides recommendations...
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Medical Devices
Indonesia Ministry of Health Published News Regarding The Draft Health Law …
Indonesia Ministry of Health published news regarding The Draft Health Law is a Solution for...
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Medical Devices
FDA Issues Final Guidances to Assist with Transition Plans for COVID-19-Rel…
The final transition guidances provide recommendations and clarity for medical device manufacturers that may or...
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Medical Devices
US FDA Issues Guidance of “Assembler’s Guide to Diagnostic X-Ra…
This document supersedes Assembler’s guide to diagnostic x-ray equipment: responsibilities of assemblers, distributors, and dealers...
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Medical Devices
Canada Updated Guidance on Applying for a Manufacturer’s Certificate …
Health Canada implemented an electronic version of the manufacturer’s certificate to export on January 5,...
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