B-205826: Mar 16, 1982

A firm protested the anticipated rejection of its bid to supply hydrocortisone by the Defense Logistics Agency (DLA) on the basis that it was not a responsible bidder. A preaward quality survey performed by the Food and Drug Administration (FDA) at the request of DLA revealed that the protester's product required a new drug application (NDA) or an abbreviated new drug application (ANDA) as a prere...

B-205826: Mar 16, 1982

DIGEST: DETERMINATION BY FOOD AND DRUG ADMINISTRATION (FDA) THAT SUPPLIER OF DRUG IS UNACCEPTABLE BECAUSE IT DOES NOT POSSESS AN APPROVED APPLICATION "AND A. " WHICH FDA FINDS IS REQUIRED FOR MARKETING THE DRUG. IS NOT SUBJECT TO REVIEW BY GAO. ON THE BASIS THAT PARAMEX IS NOT A RESPONSIBLE BIDDER. PARAMEX ASSERTS THAT FDA IS INCORRECT THAT AN AND A OR NDA IS REQUIRED FOR THE HYDROCORTISONE IN QUE...