By Jay W. Cormier & Diane B. McColl – This past Tuesday, FDA issued a Notice of Opportunity for Hearing (NOOH) proposing to withdraw approval of all new animal drug applications for carbodox that have an indication for use in medicated swine feed. Specifically, FDA is …
By Jay W. Cormier – On December 8, 2015, FDA issued a complex set of approvals for a unique product, Kanuma (sebelipase alfa). Kanuma is indicated for the treatment of a rare disease known as lysosomal acid lipase (LAL) deficiency. The list of distinguishing descriptors for the …
By Jay W. Cormier – At long last, yesterday FDA approved AquaBounty’s AquAdvantage Salmon. The approval includes a number of related actions from FDA. As part of the approval, and as required by the National Environmental Policy Act (NEPA), FDA issued a Finding of No Significant Impact …
By Karla L. Palmer – The U.S. Government Accountability Office (GAO) recently published a Report concerning animal drug compounding, titled “FDA Could Improve Oversight with Better Information and Guidance.” The Report is a result of a Congressional request for GAO to review issued related to animal …
By Ricardo Carvajal – In an unusually public manner, FDA announced the issuance of an assignment to its field staff to collect official samples of raw food intended for consumption by dogs or cats. The samples will be analyzed for Salmonella, Listeria monocytogenes, E. coli O157:H7, and non-O157:H7 Shiga toxin-producing E. coli (known …
By Karla L. Palmer – In addition to FDA’s request for nominations for bulk substances that may be used by outsourcing facilities for compounding animal medications (here) and draft guidance on compounding animal drugs from bulk substances (here), FDA also announced earlier this week that it is seeking comments on specific …
By Kurt R. Karst – On May 19th, the House Committee on Energy and Commerce took up consideration of the 21st Century Cures Act. The bill, H.R. 6, is a 309-page behemoth that was officially introduced on May 19th, and is the fourth iteration of the …
By Karla L. Palmer – Notwithstanding recognizing that sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) apply to compounding of human drug products, earlier this week the Food and Drug Administration (FDA) issued draft guidance on animal drug compounding, including compounding by section 503B outsourcing facilities. FDA …
By Karla L. Palmer – The Food and Drug Administration (FDA) announced earlier this week that it is seeking nominations for bulk substances that may be used by outsourcing facilities to compound drugs for use in animals. FDA will ultimately include the listed substances in Appendix …
By Kurt R. Karst – Amidst concern that the 2013 sequester could make a repeat appearance and reduce both FDA’s budget from Congress and industry-financed user fees to the Agency, Representatives Anna Eshoo (D-CA) and Leonard Lance (R-NJ) have introduced legislation to exempt FDA user fees …
By Kurt R. Karst – In a 2-1 decision handed down last week, a panel of judges from the U.S. Court of Appeals for the Second Circuit reversed both a March 2012 decision and a June 2012 decision from the U.S. District Court for the Southern …
By Ricardo Carvajal – FDA finalized three guidance documents that address various aspects of the use of nanotechnology in products regulated by the agency: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology, Safety of Nanomaterials in Cosmetic Products, and Assessing the Effects of Significant …
By Kurt R. Karst – On May 29th, the U.S. House of Representatives Committee on Appropriations voted 31-18 during a mark-up session to send to the House floor its version of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015, along …
By Ricardo Carvajal – FDA announced that it has implemented a new electronic reporting tool for livestock animal food problems, which the agency refers to as the Livestock Food Reporting Portal. Essentially, the portal expands the categories of reports that can be submitted through the Safety …
By Ricardo Carvajal & Kurt R. Karst – According to contingency plans drawn up by the Department of Health and Human Services, 45% of FDA’s nearly 15,000 staff were to be furloughed in the absence of enacted annual appropriations – popularly referred to as a …
