September 8, 2014
The U.S. Food and Drug Administration announced today it is soliciting public comment on expanding the availability of conditional approvals for new animal drugs.
Currently, conditional approvals are only available for new animal drugs that are intended for use in minor species (such as zoo animals) or for minor uses in major species (such as rare diseases in horses, cattle, pigs, dogs, cats, chickens or turkeys). A conditional approval allows a drug manufacturer to market its new animal drug before submitting the effectiveness data necessary for a full approval, but after proving the drug is safe in accordance with the full FDA approval standard and showing that there is a reasonable expectation of effectiveness.
The FDA is considering expanding the use of conditional approval in accordance with Animal Drug User Fee Amendments of 2013 (ADUFA III) performance goals. ADUFA III authorizes the FDA to collect user fees from animal drug sponsors to expedite and modernize the animal drug review processing exchange for FDA agreeing to meet a comprehensive set of performance goals to show significant improvement in the timeliness and predictability of the new animal drug review process. The FDA invites public comment as the agency explores this change.
The FDA is accepting public comments beginning on September 9, 2014. To submit your comments electronically to the docket, go to www.regulations.gov and type FDA-2014-N-1049 in the search box. Please note that the docket will not be open to accept comments until this date. The comment period will close on March 9, 2015. While comments are welcome at any time, you should submit them by the closing date in order for your comments to be considered in drafting recommendations by September 30, 2015 in accordance with the ADUFA III performance goals.
To submit your comments to the docket by mail, use the following address. Be sure to include docket number FDA-2014-N-1049 on each page of your written comments.
Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Federal Register Notice: Exploring the expansion of conditional approval to appropriate categories of new animal drugs Regulations.gov
Please note that the public comment period opens on September 9, 2014.