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November 16, 2018
On Tuesday, November 13th, FDA proposed to add an exception to its informed consent requirements for minimal risk FDA-regulated clinical investigations. Under the Agency’s current regulations,...
November 2, 2018
On December 13, 2016, the 21st Century Cures Act was signed into law with the intention of speeding FDA’s approval time for drugs and medical devices. When signed, the Cures Act increased FDA’s...
October 22, 2018
On Friday, October 12th, FDA issued a guidance document entitled “Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations.” The document aims to help...
October 18, 2018
Sponsors may transfer any or all of their many tasks and obligations relating to clinical trials to Contract Research Organizations (CROs). This ability to delegate through a Transfer of Regulatory...