FDA has issued a new guidance document “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic”

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-pandemic

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FDA Issues Final Guidance “Use of ISO 10993-1…”

FDA has issued a final guidance on Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”. 

The document, issued on June 16th, can be accessed through the following link:

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm348890.pdf

There will also be a webinar on the final guidance on July 21, 2016. It will take place from 1:00 -2:30 PM, Eastern Time. For more information use the following link:

http://www.fda.gov/medicaldevices/newsevents/workshopsconferences/ucm507235.htm

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Upcoming Courses with CfPA

Dr. Gad frequently teaches courses, through the Center for Professional Advancement (CfPA), on various broad-based topics in toxicology.

Listed below are his upcoming courses, all of which are open for registration!

To take advantage of our 10% Course Director Referral Discount, when you register simply use the code CD508. We look forward to seeing you!

Non-Clinical Drug Safety Evaluation and Drug Development:

July 20-22, 2016
Burlingame, CA

Course offering: 1607-403; Course ID: 1153
Register at: http://www.cfpa.com/CourseDescription/CourseDescription/1607-403/1153

Impurities, Leachables and Extractables Qualification:

August 22-23, 2016
Chicago, IL

Course offering: 1608-403; Course ID: 2703
Register at: http://www.cfpa.com/CourseDescription/CourseDescription/1608-403/2703

Safety Assessment for Medical Devices and Combination Products:

August 24-26, 2016
Chicago, IL

Course offering: 1608-404; Course ID: 719
Register at: http://www.cfpa.com/CourseDescription/CourseDescription/1608-404/719

Impurities, Leachables and Extractables Qualification:

3-4 October 2016
Amsterdam, The Netherlands

Course offering: 1610-105; Course ID: 2703
Register at: http://www.cfpa.com/CourseDescription/CourseDescription/1610-105/2703

Non-Clinical Drug Safety Evaluation and Drug Development:

5-7 October 2016
Amsterdam, The Netherlands

Course offering: 1610-106; Course ID: 1153
Register at: http://www.cfpa.com/CourseDescription/CourseDescription/1610-106/1153

Safety Assessment for Medical Devices and Combination Products:

14-16 November 2016
Amsterdam, The Netherlands

Course offering: 1611-306; Course ID: 719
Register at: http://www.cfpa.com/CourseDescription/CourseDescription/1611-306/719

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