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:
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
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
Gad Consulting Services
4008 Barrett Drive, Suite 201
Raleigh, NC 27609
Phone: (919) 233-2926
Fax: (919) 233-2927
Our Mission
We are a small organization priding ourselves on offering timely, quality, and cost effective services in the pharmaceutical area.
We have successfully filed 93 INDs and led twenty-four firms completely through to IND filing and completion of Phase I.