Inactive

The U.S. Food & Drug Administration (FDA) intends to issue a Sole Source follow-on award to the University of Maryland for continuing existing clinical studies. The Government intends to issue a sole ... The U.S. Food & Drug Administration (FDA) intends to issue a Sole Source follow-on award to the University of Maryland for continuing existing clinical studies. The Government intends to issue a sole source award in accordance with FAR 6.302-1, only one responsible source and no other will satisfy the agency requirements for the above stated service. The scope of the existing work is to continue ongoing stability studies to confirm the stability of tablets that shall be provided to the FDA for an in vivo BE study and to present the FDA with tablets that are packaged in a manner that will enhance the stability and integrity of the individual tablets.