Priority Review Vouchers/ Opioid Policy Steering Committee/ REMS Platform Standards Initiative/ FDA Clinical Trial Requirements

Priority Review Vouchers/ Opioid Policy Steering Committee/
REMS Platform Standards Initiative/ FDA Clinical Trial Requirements

1. FDA announces FY 2018 fees for using a Tropical Disease Priority Review Voucher, Rare Pediatric Disease Priority Review Voucher, and Material Threat Medical Countermeasure Priority Review Voucher

The FDA is announcing the fiscal year (FY) 2018 fee rates for using tropical disease, rare pediatric disease, and material threat medical countermeasure priority review vouchers.

The Federal Register establishes the tropical disease priority review fee rate for FY 2018 as $2,830,579 and outlines FDA’s process for implementing the collection of the priority review user fees.

The Federal Register establishes the rare pediatric disease priority review fee rate for FY 2018 at $2,830,579 and outlines FDA’s procedures for payment of rare pediatric disease priority review user fees.

The Federal register establishes the material threat medical countermeasure (MCM) priority review fee rate for fiscal year FY 2018 at $2,830,579 and outlines the payment procedures for such fees.

These rates are effective on October 1, 2017, and will remain in effect through September 30, 2018.

2. Opioid Policy Steering Committee; Establishment of a Public Docket; Request for Comments

The FDA is establishing a public docket to solicit suggestions, recommendations, and comments from interested parties, including patients and patient representatives, health care professionals, academic institutions, regulated industry, and other interested organizations, on questions relevant to FDA’s newly established Opioid Policy Steering Committee (OPSC). Learn more in the Federal Register Notice.

3. Range of Risk Evaluation and Mitigation Strategies Platform Standards Initiative: Needs Assessment;

FDA is seeking public input on the design of the REMS Platform Standards Initiative, as well as methods and best practices for its construction. To facilitate this, FDA is making available the ‘‘REMS Platform Standards Initiative: Needs Assessment’’ (needs assessment), which summarizes a range of REMS activities that could be standardized and integrated into the health care system through the use of electronic data standards. Learn more in the Federal Register Notice.

4. FDA Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice; Public Workshop

FDA is announcing an educational conference co-sponsored with the Society of Clinical Research Associates (SOCRA). The public workshop on FDA’s clinical trial requirements is designed to aid the clinical research professional’s understanding of the mission and authority of FDA and to facilitate interaction with FDA representatives. The program will focus on the relationships among FDA and clinical trial staff, investigators, and institutional review boards (IRBs). Individual FDA representatives will discuss the informed consent process and informed consent documents; regulations relating to drugs, devices, and biologics; and inspections of clinical investigators, IRBs, and research sponsors.  The workshop will be held on November 15 and 16, 2017, at the Wyndham Lake Buena Vista Resort, 1850 Hotel Plaza Blvd., Lake Buena Vista, FL 32830.

Additional information is available in the Federal Register Notice.