February 18, 2000
INFORMATION ON APPROVAL OF SUPPLEMENTAL APPLICATIONS FOR NEW ANIMAL DRUGS AVAILABLE
As required by the Food and Drug Administration Modernization Act of 1997 (FDAMA), the FDA's Center for Veterinary Medicine (CVM) is making available information regarding the approval of supplemental applications for approved new animal drugs. As part of this process, CVM has made available for comment a draft guidance document for industry entitled "Development of Supplemental Applications for Approved New Animal Drugs" (Guidance Document #82). This draft guidance, announced in the February 8, 2000 Federal Register, explains how drug sponsors can use existing data contained within an original application to support category II supplemental applications.
Copies of this draft guidance document may be obtained from CVM's Guidelines and Guidances Page or by calling or writing CVM's Communications Staff at FDA/Center for Veterinary Medicine, HFV-12, 7500 Standish Place, Rockville, MD 20855, 301-594-1755. Additional information on this subject may be obtained from Dr. Marilyn N. Martinez, Office of New Animal Drug Evaluation (HFV-130), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855.
Written comments on this draft guidance document should be submitted by May 8, 2000, to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.
In addition to this draft guidance, CVM is publishing standards for the prompt review of supplemental applications and referencing an existing guidance that describes how supplemental applications may qualify for priority review. This existing guidance (CVM Program Policy and Procedures Guide 1240.3135) outlines the circumstances in which CVM may make a determination that a product represents an important advance in animal health. Upon rendering this determination, FDA may expedite the review of original and supplemental applications.
Copies of this existing guidance document "Animal Drug Applications; Expedited Review Guideline" may be obtained from CVM's Home Page on the Internet or by calling or writing CVM's Communications Staff at the address above. Comments on this CVM Program Policy and Procedures Guide may be submitted at any time to the Policy and Regulations Team (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855.
CVM is also designating an individual within the Center who is responsible for encouraging the prompt review of supplemental applications and for working with sponsors to facilitate the development and submission of data to support supplemental applications. Further, CVM is describing its efforts to collaborate with other organizations and persons to identify published and unpublished studies that may support supplemental applications and to encourage sponsors to submit supplemental applications based on such studies.
Additional information on this subject may be found in the February 8, 2000, Federal Register. Information about draft guidance #82 may be obtained from Dr. Marilyn N. Martinez, Office of New Animal Drug Evaluation (HFV-130), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-7577. Additional information about other parts of this Federal Register notice may obtained from Dr. Carol Haley, Office of the Director (HFV-6), CVM, FDA, 7500 Standish Place, Rockville, MD 20855, 301-594-1682.
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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