Comment Period Reopens on June 10, 2015. More Information.

The Food and Drug Administration (FDA) is announcing a public meeting to discuss the use of in vitro methods as a mechanism for assessing the in vivo product bioequivalence (BE) of non-systemically absorbed drug products intended for use in veterinary species. FDA is seeking additional public comment to the docket.

Date and Time: The one day public meeting will be held on April 16, 2015, from 9:00 a.m. until 4:00 p.m.

Location: The public meeting will be held at the Center for Veterinary Medicine, FDA, 7519 Standish Place, 3rd Floor, Conference Rm A, Rockville, MD 20855. Parking is free.

Contact Person: Aleta Sindelar, CVM, FDA; 7519 Standish Place, Room 144, Rockville, MD 20855, 240-276-9230; Fax 240-276-9241; email address [email protected].

Registration: Registration is free and available on a first come, first served basis. Persons interested in requesting an opportunity to speak during the open public comment period must register by April 8, 2015, and must include a brief summary of comments with their registration. Those individuals will be contacted prior to the meeting regarding their participation. Persons interested in attending this meeting who are not requesting an opportunity to speak at the meeting must register by April 14, 2015. For general questions about the meeting, for assistance registering for the meeting, to request an opportunity to make an oral presentation, or to request special accommodations due to a disability, contact: Aleta Sindelar, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., rm. 144, Rockville, MD 20855, 240-276-9230, FAX: 240-276-9241, Email: [email protected]. Please include your name, organization, and contact information. Early registration for the meeting is encouraged due to limited time and space.

Attend Meeting Virtually: https://collaboration.fda.gov/cvm_bioequivalence_meeting/

Additional Information

• Notice of Public Meeting: Identification of Alternative In Vitro Bioequivalence Pathways
• References
• Draft Agenda for Public Meeting on Identification of Alternative In Vitro Bioequivalence Pathways
• Reopening of Comment Period: Identification of Alternative In Vitro Bioequivalence Pathways; Request for Comments

Presentations

• Importance of In Vitro Bioequivalence Pathways
• FDA/CVM Demonstrating Bioequivalence
• In Vitro Bioequivalence (BE) Pathways
• The Use of In Vitro Bioequivalence as a Regulatory Approach
• Meeting Summary and Next Steps