FDA To Host Meetings On Drug Fee Programs

Duo of public meetings date set for November 7th, 2011 issued by the U.S. Food and Drug Administration.

The U.S. Food and Drug Administration will hold a pair of public meetings on Monday, Nov. 7, 2011, to receive feedback on its drug user fee programs for the animal health industry, the agency reported today.

The Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA) give the FDA authority to collect user fees from the animal health industry and use those fees to make the drug approval process faster and more predictable.

The current ADUFA and AGDUFA programs expire on Sept. 30, 2013, and the FDA is seeking public comment on the overall performance of the programs and the aspects of the programs that should be retained, changed or discontinued to strengthen the programs.

The meetings will be held at the FDA’s Center for Veterinary Medicine in Rockville, Md. Those wishing to attend or make a presentation can register by emailing ADUFAReauthorization@fda.hhs.gov for the ADUFA meeting, which will be held from 9 a.m. to noon EST, or AGDUFAReauthorization@fda.hhs.gov for the AGDUFA meeting, which will be held from 1 p.m. to 4 p.m. EST.

The email should contain each attendee’s name, title, affiliation, address, email and phone number, as well as which stakeholder group the attendee belongs to, including scientific or academic experts; veterinary professionals; patient and consumer advocacy groups; or the regulated industry. Onsite registration on the day of the public meeting will be based on space availability, and the time allotted for presentations will depend on the number of presenters.

Comments can also be submitted electronically here or by mail to Divisions of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm 1060, Rockville, MD 20852.


Post a Comment


bocoran admin jarwo