Drug Regulators, FDA, Introduce New IRB registration Rules
Clinical Trials Regulations have been changed following on from the Coast scandal reported in this site (article). I have just received this update from the ICR
The FDA IRB Registration Rule is effective Tuesday, July 14, 2009. All IRBs reviewing FDA-regulated research must register between July 14 and September 14, 2009. IRBs that review FDA-regulated studies and that are not already in the OHRP IRB registration system must submit an initial registration. If your IRB is already registered in the OHRP system, the registration information must be updated to include all of the information required by the FDA IRB Registration Rule. Please see the guidance referenced below for more information.
This registration will be accomplished through a modified version of the database used by the Office for Human Research Protections (OHRP).Please note: the database for electronic submission of IRB registrations will not be available until July 14, 2009.
If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com
Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
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