Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention.'' The purpose of this guidance is to assist sponsors in the clinical development of drugs for the prevention of delayed graft function (DGF) in kidney transplantation.
Center for Devices and Radiological Health: Experiential Learning Program
The Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH or Center) is announcing the 2017 Experiential Learning Program (ELP). This training component is intended to provide CDRH staff with an opportunity to understand the policies, laboratory practices, patient perspective/input, quality system management, and other challenges that impact the device development life cycle. The purpose of this document is to invite medical device industry, academia, and health care facilities, and others to participate in this formal training program for CDRH's employees, or to contact CDRH for more information regarding the ELP.
Proposed Substances To Be Evaluated for Set 31 Toxicological Profiles
The Agency for Toxic Substances and Disease Registry (ATSDR) located in the Department of Health and Human Services (HHS) is initiating the development of its 31st set of toxicological profiles (Set 31). Today's announcement invites voluntary public nominations of substances for profile development. ATSDR is soliciting public nominations of substances found on the Substance Priority List (SPL) at https://www.atsdr.cdc.gov/spl.
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
This publication corrects a notice that was published in the Federal Register on March 9, 2017 Volume 82, Number 45, page 13119. The meeting announcement and matters for discussion should read as follows: The meeting announced below concerns the Centers for Disease Control and Prevention (CDC) initial review of applications in response to Funding Opportunity Announcements (FOA) GH13-001, Strengthening Disease Prevention Research Capacity for Public Health Action in Guatemala and the Central American Region; FOA GH14-002, Addressing Emerging Infectious Diseases in Bangladesh; and FOA GH16-003, Conducting Public Health Research in Thailand: Technical collaboration with the Ministry of Public Health in the Kingdom of Thailand (MOPH). Matters for Discussion: The meeting will include the initial review, discussion, and evaluation of applications received in response to ``Strengthening Disease Prevention Research Capacity for Public Health Action in Guatemala and the Central American Region'', FOA GH13- 001; ``Addressing Emerging Infectious Diseases in Bangladesh'', FOA GH14-002; and ``Conducting Public Health Research in Thailand: Technical collaboration with the Ministry of Public Health in the Kingdom of Thailand (MOPH)'', FOA GH16-003.