Latest Federal Register Notices

ANIMAL DRUGS

Guidance on Animal Drug Bioequivalence Waivers
Federal Register Notice: FDA has made available a revised guidance for industry (#171) on “Waivers from the Requirement to Demonstrate Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles.” The document describes how CVM intends to evaluate requests for waiving the requirement for submitting data demonstrating the bioequivalence of animal drugs in soluble powder oral dosage form products and Type A medicated articles. To view the guidance, click here. To view this notice, click here.

Withdrawal of NADA for Three-way Type A Medicated Drug
Federal Register Notice: FDA is withdrawing approval for parts of a new animal drug application (NADA) for a three-way, fixed-ratio, combination drug Type A medicated article that pertains to use of the procaine penicillin component for production indications in swine. The withdrawal is being taken at the sponsor’s request because the three-way Type A medicated article is no longer manufactured. To view this notice, click here.

Comments Sought on Antimicrobials Used in Animal Feed/Water
Federal Register Notice: FDA is seeking comments on establishing appropriately targeted durations of use for antimicrobial drugs which are important for human use, when they are administered in the feed or water of food-producing animals for therapeutic purposes. The request for comments is part of the government’s National Action Plan for Combating Antibiotic-Resistant Bacteria. FDA says its  current methodology for assessing antimicrobial risks associated with the use of new animal drugs antibiotics in food-producing animals is premised on the concept that increasing the exposure of bacterial populations to antimicrobial drugs increases the risk of generating resistance to those antimicrobial drugs. Because feed- or water-use antimicrobial drugs are typically administered to entire herds or flocks of food-producing animals, such uses pose a higher risk to public health than the administration of such drugs to individual animals or targeted groups of animals, as is done with dosage form drugs. Comments are due by 12/13. To view this notice, click here.

BIOLOGICS

Guidance on Gene Therapy Microbial Vector Recommendations
Federal Register Notice: FDA has released a guidance on “Recommendations for Microbial Vectors Used for Gene Therapy” that provides recommendations concerning IND submissions for microbial vectors used for gene therapy in early phase clinical trials. The guidance focuses on the chemistry, manufacturing, and control information that sponsors should submit in an IND for such products, and provides an overview of preclinical and clinical considerations. To view the guidance, click here. To view this notice, click here.

FDA Cancels Dynavax Vaccine Committee Meeting
Federal Register Notice: FDA has canceled an 11/16-planned meeting of the Vaccines and Related Biological Products Advisory Committee that was scheduled to review a hepatitis B vaccine manufactured by Dynavax. FDA says the cancelation will allow time for the agency to review and resolve several outstanding issues. A future advisory committee meeting will be rescheduled as needed. To view this notice, click here.

Guidance on Using Nucleic Acid Tests for West Nile Testing
Federal Register notice: FDA has released 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 (HCT/Ps).” The document provides establishments that make donor eligibility determinations for donors of HCT/Ps with recommendations for testing living donors for West Nile Virus. To view this guidance, click here. To view this notice, click here.

DEVICES

Comments Sought on Unique Device Identifier Requirements
Federal Register Notice: FDA is seeking comments on a proposed collection of information related to the agency’s Unique Device Identification (UDI) System. Comments are sought on requirements for medical device labelers to include an expiration date, a date of manufacture, or any other date intended to be brought to the attention of device users, and requirements on the format of UDI labels, among other UDI requirements. To view this notice, click here.

Workshop on Coordinated Antibiotic, Related Test Development
Federal Register Notice: FDA has planned a public workshop on “Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices (ASTs). It is intended to facilitate discussion between drug sponsors and device manufacturers who are planning to develop new antimicrobial drugs or ASTs and who wish to coordinate development of these products to obtain device clearance either at the time of NDA approval or shortly thereafter. The workshop will be held 9/29 at the Sheraton Silver Spring Hotel (Silver Spring, MD). To view this notice, click here.

HUMAN DRUGS

Guidance on Total Kidney Volume Biomarker
Federal Register Notice: FDA is making available a guidance on “Qualification of Biomarker — Total Kidney Volume in Studies for Treatment of Autosomal Dominant Polycystic Kidney Disease.” The document provides a qualified context of use for total kidney volume, measured at baseline, to be used as a prognostic enrichment biomarker to select patients with autosomal dominant polycystic kidney disease at high risk for a progressive decline in renal function. The document also describes the experimental conditions and constraints for which this biomarker is qualified through CDER’s Biomarker Qualification Program. To view the guidance, click here. To view this notice, click here.

FDA, University of MD Host Clinical Investigator Training
Federal Register Notice: FDA and the University of Maryland Center of Excellence in Regulatory Science and Innovation have planned a three-day (11/7-9) training course for clinical investigators. It is intended to provide expertise in the design, conduct, and analysis of clinical trials; to improve the quality of clinical trials; and to enhance the safety of trial participants. The course will be held at the Silver Spring Civic Building at Veterans Plaza (Silver Spring, MD). To view this notice, click here.

Guidance on Plasma Fibrinogen Biomarker Qualification
Federal Register notice: FDA has released a guidance on “Qualification of Biomarker — Plasma Fibrinogen in Studies Examining Exacerbations and/or All-Cause Mortality for Patients With Chronic Obstructive Pulmonary Disease (COPD).” The document provides a qualified context of use for plasma fibrinogen in COPD interventional clinical trials for patients at high risk for exacerbations or all-cause mortality. To view this guidance, click here. To view this notice, click here.