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On August 11, 2022, the U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) will host a virtual public meeting on the FDA’s oversight of advanced manufacturing technologies for animal drugs. The meeting will be a listening session to provide stakeholders with an opportunity to share information and insight on this topic with CVM, and will take place from 1:00-4:00 p.m. EDT, via Zoom.

CVM regulates manufacturing, including advanced manufacturing, of animal drug products. Advanced manufacturing includes a variety of new manufacturing technologies or technologies used in an innovative way that may improve drug quality, address drug shortages, and speed time-to-market. Examples of advanced manufacturing technologies include but are not limited to continuous manufacturing, advanced process control, and additive manufacturing (i.e., 3D printing). 

CVM is requesting comments and presentations from stakeholders regarding the current implementation and use of advanced manufacturing technologies. Topics may include economic impact, implementation, and production benefits and challenges. Additionally, CVM is requesting feedback on how the Center may further aid animal drug sponsors in adopting advanced manufacturing technologies, such as providing an alternate pathway for submissions (similar to the Center for Drug Evaluation and Research’s Emerging Technology Program), granting Barrier to Innovation user fee waivers to help offset the upfront costs of adopting advanced manufacturing technologies, reducing regulatory burden through a Quality Management Maturity rating program, or the creation of new programs to aid in the process of adopting advanced manufacturing technology.

The virtual public meeting on advanced manufacturing is made possible through funding provided by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).

Registration

Stakeholders interested in attending the virtual public meeting should register no later than August 8, 2022, at 11:59 p.m. ET, by completing this registration form: Registration – 2022 FDA CVM Advanced Manufacturing Public Meeting. Early registration is recommended. Registrants will receive confirmation of registration and an email with the webcast link. 

If you are interested in presenting at the virtual public meeting, register no later than July 20, 2022, at 11:59  p.m. ET, by filling out the registration form and checking off the box indicating that you would like to present. The FDA will contact presenters by July 25, 2022, with additional instructions. 

Public Comments

In addition to holding the virtual public meeting, the FDA is accepting electronic or written comments through September 10, 2022. To electronically submit comments to the docket, visit regulations.gov.

The public may also submit comments by mail using the address below: 

Dockets Management Staff
HFA-305
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

All submissions received must include the Docket No. FDA-2022-N-1244.

Meeting Recording

A recording of the webinar will be posted on this webpage when available.

Additional Information

• Advanced Manufacturing

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