FDA Altering Policies on Publishing Memoranda of Understanding

The US Food and Drug Administration (FDA) announced Friday it will stop publishing written agreements and memoranda of understanding (MOU's) in the Federal Register, and will instead be opting to publish the agreement solely on its website.

The 23 March Federal Register final rule claims the existing regulatory policy is no longer necessary, and eliminates the requirement effective 6 August 2012.

FDA currently uses MOUs to generate agreements between US agencies and departments, as well as foreign governments and outside organizations.

The MOUs will henceforth be posted to one of three FDA webpages:

• FDA's webpage for domestic agreements
• FDA's webpage for academic agreements
• FDA's webpage for all other agreements

FDA has also published a companion Federal Register posting for all public comments on the rule "in the event we receive any significant adverse comments and withdraw this direct final rule."

Read more:

Federal Register - Agreements and Memoranda of Understanding Between the Food and Drug Administration and Other Departments, Agencies, and Organizations (Final Rule)

Federal Register - Agreements and Memoranda of Understanding Between the Food and Drug Administration and Other Departments, Agencies, and Organizations (Companion Rule)