MCMi in Action: How FDA works to protect national health and security

Protecting National Health and Security

FDA plays a critical role in protecting the United States from chemical, biological, radiological, nuclear, and emerging infectious disease threats

FDA ensures that medical countermeasures (MCMs)—including drugs, vaccines and diagnostic tests—to counter these threats are safe, effective, and secure. FDA’s Medical Countermeasures Initiative (MCMi) is an FDA-wide initiative to coordinate MCM development, preparedness and response. FDA helps facilitate development and availability of MCMs by providing scientific and regulatory advice, including during public health emergency situations, like Zika virus outbreaks. FDA protects the blood supply, and we protect consumers from false product claims and counterfeit products, while communicating and collaborating with U.S. government and international partners, and medical product developers. When necessary, we enable access to investigational MCMs through an appropriate mechanism such as Emergency Use Authorization (EUA). Related information MCMi in Action - more about how FDA is protecting national health and security Frequently requested MCM links, organized by audience Stay up-to-date: bookmark the MCMi news and events page

Biosimilar educational materials for health care professionals

FDA is pleased to announce the release of new educational materials for health care professionals about biosimilar and interchangeable products. The agency developed these educational materials to help increase understanding about these important new types of medication among health care professionals.

Events October 31, 2017: FDA's CDRH will host a webinar to discuss the final guidance Evaluation and Reporting of Age, Race, and Ethnicity-Specific Data in Medical Device Clinical Studies (PDF, 1.1 MB) from 12:00 - 1:30 p.m. ET. On the day of the webinar, use this link to view the presentation and enter conference number: PWXW5467008. To hear the presentation and ask questions: Dial: 888-566-6150; passcode 7300669 | International: 1-212-287-1854; passcode 7300669. New! November 7, 2017: The  Vaccines and Related Biological Products Advisory Committee (VRBPAC) will hold a public meeting (Silver Spring, MD and webcast) to discuss and make recommendations on the clinical development plan for Pfizer's investigational Staphylococcus aureusvaccine intended for pre-surgical prophylaxis in elective orthopedic surgical populations. November 7-8, 2017: BARDA Industry Day, hosted by HHS/ASPR (Washington, DC) - FDA will present New! November 9, 2017: FDA Grand Rounds - Assessing the safety and effectiveness of new and emerging therapeutic ultrasound technologies, presented by Greg Clement, PhD, FDA/CDRH New! November 15-16, 2017: FDA Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice - FDA and the Society of Clinical Research Associates (SOCRA) will host a public workshop on FDA's clinical trial requirements (Lake Buena Vista, FL) (fee) New! November 16, 2017: Public hearing - Devices Referencing Drugs (Silver Spring, MD and webcast) - This hearing will discuss a potential approach for premarket review of medical devices intended for a new use with an approved, marketed drug when the sponsor for the approved drug does not wish to pursue or collaborate on the new use. FDA has outlined a potential approach for premarket review of proposed devices referencing drugs (DRDs) and invites public input on this potential approach during this hearing and through comments to the hearing docket. To attend or present at the hearing, register by October 26, 2017.

Information for industry FDA's CDRH invites medical device industry, academia, and health care facilities, and others to participate in the 2018 Experiential Learning Program, a formal training program for FDA staff. Submit responses by November 1, 2017, 12:00 p.m. ET. Draft guidance - Format and Content of a REMS Document (PDF, 166 KB) - This revised draft guidance describes a new recommended format for a Risk Evaluation and Mitigation Strategy (REMS) document, based on extensive stakeholder feedback. This guidance revises and supersedes the draft guidance entitled “Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications,” that was published by FDA on October 1, 2009. Comment by December 11, 2017. Related: REMS Basics, REMS@FDA database of approved REMS(October 12, 2017) Draft guidance - Breakthrough Devices Program (PDF, 257 KB) - This program is intended to help patients have more timely access to devices and breakthrough technologies that provide for more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases, for which no approved or cleared treatment exists or that offer significant advantages over existing approved or cleared alternatives. This guidance describes the policies that the agency intends to use to implement the program. Comment by December 26, 2017. (October 25, 2017) More: MCM-Related Guidance by Date

In case you missed it FDA Fast Facts: FDA’s Support of the Hurricane Relief Effort - also see October 20, 2017 Statement from FDA Commissioner Scott Gottlieb, MD, on medical device manufacturing recovery in Puerto Rico  FDA Releases 2015 National Antimicrobial Resistance Monitoring System (NARMS) Integrated Report - Partnership with CDC and USDA tracks antimicrobial resistance patterns to protect public health - view the report (October 23, 2017) FDA is requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels. Consumer organizations interested in participating in the selection of consumer representatives should notify FDA in writing. The deadline for both is November 15, 2017.  The National Association of County and City Health Officials (NACCHO) is extending the deadline to submit an abstract for the 2018 Preparedness Summit, which will now close on October 29, 2017 at 11:59 p.m., PT. From HHS - Acting Secretary Hargan declares public health emergency in California due to wildfires - also see 2017 California Wildfires (HHS ASPR) (October 15, 2017) From CDC - CDC updates guidance for infants born to mothers with possible Zika virus infection during pregnancy - CDC issued updated interim clinical guidance for health care providers caring for infants born to mothers with possible Zika virus infection during pregnancy. This update includes information that has become available since the August 2016 release of the previous guidance. Also see MMWR - Update: Interim Guidance for the Diagnosis, Evaluation, and Management of Infants with Possible Congenital Zika Virus Infection — United States (October 20, 2017) From NIH - Experimental Ebola vaccines elicit year-long immune response - NIH reports final data from large clinical trial in West Africa - also see Phase 2 Placebo-Controlled Trial of Two Vaccines to Prevent Ebola in Liberia (NEJM) (October 12, 2017) From EPA - The Environmental Protection Agency (EPA) Publishes Two Essential Communication Resources for Radiation Emergencies - These companion documents to the EPA’s Protective Action Guide (PAG) Manual will help emergency responders prepare public communication materials prior to and during a radiological emergency. View the new documents and related materials: PAG Public Communications Resources (October 11, 2017)