FDA-TRACK Newsletter April 2021
FDA-TRACK Releases New Performance Dashboards for CVM
FDA-TRACK launched new and enhanced performance measure dashboards for the Center for Veterinary Medicine (CVM), highlighting its accomplishments toward the center’s mission of protecting human and animal health.
To better reflect the progress the center has made toward its key initiatives, CVM has updated its existing menu of information by adding five new dashboards to its FDA-TRACK site covering its work on animal food safety; compounded animal drugs; emerging technologies; pre-market drug review; and post-market drug safety, effectiveness, and quality. The new dashboards join existing and enhanced ones covering CVM's work supporting antimicrobial stewardship in veterinary settings, as well as the center’s performance on animal drug review timelines agreed upon in the Animal Drug User Fee Act (ADUFA) and Animal Generic Drug User Fee Act (AGDUFA).
The Animal Food Safety dashboard includes information about animal food facility inspections, animal food recalls, export certificates, and safety review measures. With new appropriated resources in FY2020, CVM recently broadened the depth and range of expertise of its food safety review team and these new performance measures will allow stakeholders to better track the progress of review timeframes. In 2020, CVM also finalized Guidance for Industry #262, “Pre-Submission Consultation Process for Animal Food Additive Petitions or Generally Recognized as Safe (GRAS) Notices,” which provides non-binding recommendations for submissions to investigational food additive (IFA) files, use of foreign data in a submission, describing when the submission of study protocols is recommended, an explanation of FDA’s review process for IFA submissions, and best practices for communication between FDA and submitters regarding these regulatory submissions.
The Compounded Animal Drugs dashboard tracks CVM’s development and implementation of policies concerning animal drugs that are compounded from bulk drug substances. These products are the focus of draft Guidance for Industry #256, entitled “Compounding Animal Drugs from Bulk Drug Substances,” which CVM issued in November 2019. Since that time, CVM has regularly engaged with affected members of industry to provide clarity around the guidance and its intended purposes. The center is currently in the process of reviewing the more than 14,000 public comments received in response to the draft.
Emerging Technologies have the potential to influence multiple fields, including medicine, conservation, and agriculture. Modern molecular technologies, such as genetic engineering and genome editing, allow for the development of intentional genomic alterations (IGAs) in animals for purposes such as research into human disease, production of substances for pharmaceutical use, and as sources of cells, tissues, or organs for transplantation into humans. Other technologies such as animal cells, tissues, and cell- and tissue-based products (ACTPs) offer potential novel drug therapies for a variety of veterinary medical needs, including musculoskeletal diseases and inflammatory conditions.
The Pre-Market Animal Drug Review dashboard highlights CVM’s Animal Drug Approvals and the process for the 2023 reauthorization of ADUFA and AGDUFA. This information is in addition to existing dashboards that detail CVM’s performance under the current authorizations of ADUFA and AGDUFA.
The Post-Market Drug Safety, Effectiveness, and Quality dashboard highlights work performed by CVM to ensure that FDA-approved animal drugs continue to be safe, effective, and manufactured according to quality standards. These actions help the center protect animals and consumers from poor quality, unsafe, or ineffective animal drugs.
CVM is dedicated to its mission of protecting the health of humans and animals, and these dashboards will help provide transparency to consumers, industry, and other stakeholders about specific activities the center engages in to help achieve its mission. The dashboards will be updated on a regular basis. For more information about FDA-wide activities, see the FDA-TRACK website.