Latest Federal Register Notices
ANIMAL DRUGS
FDA Amends Animal Drug Regs for Approvals, Etc.
Federal Register Final Rule: FDA has amended the animal drug regulations to reflect application-related actions for new animal drug applications and abbreviated new animal drug applications during July and August. FDA has also made available approval summaries and environmental review documents. Additionally, the animal drug regulations have been amended to reflect a sponsor’s address change. To view the notice, click here.
BIOLOGICS
Notice on Biosimilar Public Meeting Corrected
Federal Register Notice: FDA has corrected a 9/19 notice on “Biosimilar User Fee Act; Public Meeting.” The document was published with the incorrect date of the closure of the docket, which now reads 10/28/2016. To view this notice, click here.
Notice on Biomarkers Listing Corrected
Federal Register Notice: FDA has corrected a 9/19 notice entitled "A List of Biomarkers Used as Outcomes in Development of FDA-Approved New Molecular Entities and New Biological Therapeutics (10/2007 to 12/2015).” The notice established a docket to receive suggestions, recommendations, and comments from interested parties on the list. The notice was published without an active Web link, and this notice corrects that error. To view this notice, click here.
DEVICES
Evoked Photon Image Capture Device into Class 1
Federal Register Final Order: FDA has classified the Evoked Photon Image Capture Device into Class 1 (general controls). The device is identified as a prescription, electrically-powered device intended for use as a non-invasive measurement tool that applies electricity to detect electrophysiological signals emanating from the skin, which are reported numerically and as images without clinical interpretation. The agency noted that the device is not intended for diagnostic purposes. To view this notice, click here.
Notice on West Nile Virus Guidance Corrected
Federal Register Notice: FDA has corrected a 9/13 notice on the availability of a guidance on “Use of Nucleic Acid Tests To Reduce the Risk of Transmission of West Nile Virus From Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products.” The notice was corrected to read, “Submit either electronic or written comments on agency guidances at any time.” To view this notice, click here.
DRUGS
Public Meeting for Generic Drug User Fee Reauthorization
Federal Register Notice: FDA has announced a public meeting to discuss proposed recommendations for reauthorizing the Generic Drug User Fee Amendments of 2012. The legislative authority expires 9/30/2017. The public meeting will be held 10/21 at FDA’s White Oak campus (Silver Spring, MD). To view this notice, click here.
FDA Regulatory Review Period for Ionsys is 4,835 Days
Federal Register Notice: FDA has determined the regulatory review period for a Medicines Company NDA for Ionsys (fentanyl iontophoretic transdermal system) that applies to a patent extension for the product. The agency determined that the applicable regulatory review period for the drug is 4,835 days. To view this notice, click here.
FDA Sets Tropical Disease Voucher Fee at $2.7 Million
Federal Register Notice: FDA has announced the fee rate of $2.7 million for using a tropical disease priority review voucher for fiscal year 2017. The vouchers are awarded to sponsors of certain tropical disease product applications, submitted after 9/27/2007, upon FDA approval of such applications. To view this notice, click here.
Rare Pediatric Disease Priority Voucher Fee is $2.7 Million
Federal Register Notice: FDA has announced the fee rate of $2.7 million for using a rare pediatric disease priority review voucher for fiscal year 2017. The vouchers are awarded to sponsors of rare pediatric disease product applications that meet all of the requirements of the program and were submitted 90 days or more after 7/9/2012. To view this notice, click here.
FDA GENERAL
Comments Sought on Dietary Supplement GMP Recordkeeping
Federal Register Notice: FDA has announced an opportunity for public comment on information collection related to an extension of “Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements — 21 CFR Part 111.” The collection pertains to records of personnel practices, including training documentation; records of physical plant sanitation practices, including pest control and water quality; records of equipment and utensils calibration and sanitation practices; records of production and process control systems; and records that quality control personnel must make and keep. To view this notice, click here.