August 3, 2017 | FDA Medical Countermeasures Initiative Update
Patients with serious or immediately life-threatening diseases or conditions who have no comparable or satisfactory alternative therapy and who seek access to potentially life-saving investigational drugs will have another option to guide them through the process, thanks to the launch of a new online tool called the Expanded Access Navigator.
The Expanded Access Navigator helps educate patients and physicians about the process. Most of what they need to seek expanded access is now available in this single online location, including a directory where companies can submit public links to their expanded access policies, criteria used by companies to determine whether to make a drug available through expanded access, and contact information.
The development of the Navigator was a team effort led by the Reagan-Udall Foundation in collaboration with patient advocacy groups, the pharmaceutical industry, FDA, and others in the Federal government.
- FDA Voice blog: The Expanded Access Navigator – Helping Patients In Need of Potentially Life-Saving Drug Treatments
- About the Reagan-Udall Foundation
New Zika diagnostic EUA:
Zika diagnostic EUA amendment:
Reminder: Laboratory personnel using Zika diagnostic assays under EUA are encouraged to report performance concerns directly to FDA at CDRH-EUA-Reporting@fda.hhs.gov
- NEW! August 9, 2017: CDC Second Wednesday Webinar 1:00 - 2:00 p.m. ET - panelists from CDC’s Division of State and Local Readiness and Division of Strategic National Stockpile will discuss the recently released resource Receiving 60-day Anthrax Medical Countermeasures from CDC’s Strategic National Stockpile: Planning Considerations for State, Local, Tribal, and Territorial Partners
- August 14-15, 2017: NIST-DHS Standards for Pathogen Detection for Biosurveillance and Clinical Applications Workshop (Gaithersburg, MD) - The purpose of this workshop is to present state-of-the-art pathogen detection technologies, emphasizing the need for standards relevant to the clinical diagnostic and biothreat detection stakeholder communities. Register by 11:45 a.m. ET, August 8, 2017. (fee)
- NEW! August 23, 2017: Webinar - Role of Advertising and Promotion in Adult Immunization Disparities - In honor of Immunization Awareness Month, the FDA Office of Minority Health will host a webinar featuring a panel of researchers from FDA and Howard University. The panel will discuss their research on assessing user acceptance and comprehension of vaccine advertising and promotional material for minorities.
- August 29, 2017: Regulatory/Scientific Challenges and Benefits of Repurposing Licensed Products for a Radiation Indication workshop (Rockville, MD and webcast), hosted by NIH/NIAID
- NEW! September 6-7, 2017: Zika Therapeutics Workshop (Rockville, MD), hosted by NIH/NIAID - advance registration is required
- September 8, 2017: Public workshop - Pediatric Trial Design and Modeling: Moving into the Next Decade (Silver Spring, MD and webcast) - register
- September 13, 2017: Public workshop - Antimicrobial Susceptibility and Resistance: Addressing Challenges of Diagnostic Devices (Silver Spring, MD and webcast) - To attend in person, register by 4:00 p.m. ET September 1, 2017.
- NEW! September 13, 2017: Public workshop - A Framework for Regulatory Use of Real-World Evidence (Washington, DC) - Register by September 12, 2017.
Information for industry
- Guidance - Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases (PDF, 149 KB) - This guidance finalizes the draft guidance of the same name issued July 2, 2013. (August 2, 2017)
- FDA is announcing its intent to establish a pilot project program under the Drug Supply Chain Security Act (DSCSA) to assist in development of the electronic, interoperable system that will identify and trace certain prescription drugs as these are distributed within the United States. Submit comments on this pilot program by September 18, 2017. FDA will hold 3 public meetings to provide members of the pharmaceutical distribution supply chain and other interested stakeholders an opportunity to discuss with FDA, and provide input on, strategies and issues related to the enhanced drug distribution security provisions of the DSCSA. The meetings will be held on August 23, 2017, December 5 and 6, 2017, and February 28, 2018 in Silver Spring, MD. Advance registration is required. (July 20, 2017)
- Guidance - Institutional Review Board (IRB) Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects - This guidance informs sponsors, investigators, IRBs, and other interested parties that FDA does not intend to object to an IRB waiving or altering informed consent requirements, as described in the guidance, for certain minimal risk clinical investigations. In addition, this guidance explains that FDA does not intend to object to a sponsor initiating, or an investigator conducting, a minimal risk clinical investigation for which an IRB waives or alters the informed consent requirements as described in the guidance. (Federal Register notice) (July 25, 2017)
In case you missed it
- For the first time, an FDA advisory committee will focus on patient-related issues. On October 11-12, 2017, FDA will hold the inaugural meeting of the new Patient Engagement Advisory Committee. The topic will be the challenges of clinical trial design, conduct, and reporting identified by patients. Also see the FDA Voice blogs Patient Reps – Bringing the Voice of Patients to FDA and FDA Sets Inaugural Meeting of First-Ever Patient Engagement Advisory Committee
- HHS is seeking nominations of qualified candidates to be considered for appointment as members of the Secretary's Advisory Committee on Human Research Protections (SACHRP). Submit nominations by September 18, 2017. HHS is also seeking nominations for its new Tick-Borne Disease Working Group, due August 16, 2017.
- Updated CDC Guidance for US Laboratories Testing for Zika Virus Infection - Current guidance for US laboratories testing for Zika virus infection recommends that testing be limited to specimens collected from patients meeting CDC’s clinical and epidemiologic criteria for testing - also see CDC's updated interim pregnancy guidance for symptomatic pregnant women with possible Zika virus exposure (PDF, 277 KB) (July 24, 2017)
- From CDC - Pediatrics and Public Health: Working Together to Prepare for Emergencies (July 21, 2017)