FDA seeks input on conditional approvals for new animal health products

The FDA last week issued two separate notices that it is looking for public comment on how the regulatory agency decides conditional approvals for new animal drugs as well as how it proceeds on giving its okay for combination drugs in medicated feeds.

The agency said it is looking to expand the availability of conditional approvals for new animal drugs. As it stands now, conditional approvals are only available for new animal drugs that are intended for use in minor species like zoo animals, and for minor uses in major species like horses, cattle, pigs, dogs, cats, chickens or turkeys that have been stricken with rare diseases.

Conditional approvals allow drug manufacturers to market new animal drugs before submitting effectiveness data needed for full approval but after proving the drug is safe under FDA standards. There also must be a reasonable expectation of effectiveness.

In a second notice, the agency invited public comment on possible modifications to its procedures and requirements when approving  combination drug medicated feeds.

Under current guidelines, using multiple new animal drugs in the same medicated feed requires FDA approval for each new animal drug in the combination as well as a separate approval for the combination drug itself. The agency said it is considering changes to the current process in accordance with ADUFA III performance goals.

The commentary period for both notices will close on Sept. 9, 2015.

- see the first FDA release
- see the second FDA release