"Industry rights" document from FDA to quell fears of retaliation will be written, Kessler assures Sen. Gregg.
Executive Summary
FDA "INDUSTRY RIGHTS" DOCUMENT ON RETALIATION/DISPUTE RESOLUTION will be developed by the agency's Chief Mediator and Ombudsman Office, FDA Commissioner Kessler said in a June 29 letter to Sen. Gregg (R-N.H.). "In order to enhance the industry's knowledge and use" of the Ombudsman's office, which Kessler described as a "resource" for problem resolution between industry and the agency, the commissioner has directed the office "to prepare a document that will outline industry's rights and describe the agency's processes for both retaliation and dispute resolution."