Replies to post #16707 on Rich Pharmaceuticals Inc. (fka RCHA)

[Havoc23]

Re clinical trials abroad:

http://www.phrma.org/press-release/phrma-statement-on-foreign-clinical-trials

Regardless of the location, however, companies seeking U.S. approval must maintain the FDA’s high standards for conducting the trial. For instance, any related trials conducted outside the U.S. must comply with FDA requirements covering Good Clinical Practices, in addition to meeting the requirements mandated in these important emerging markets.

“It’s important to remember that the Food and Drug Administration (FDA) has jurisdiction over clinical trials conducted in foreign countries for drugs approved in the U.S. or being studied for approval in the U.S. The same strict regulatory standards apply to foreign trials as trials conducted domestically. Sponsors are typically in communication with the FDA throughout clinical trials – no matter where they are conducted.