Zika reference materials for diagnostic manufacturers + better understanding Ebola's after-effects to help find new treatments

FDA Medical Countermeasures Initiative Update

News updates

Events:

• New! June 20, 2016: OpenFDA Public Workshop (Silver Spring, MD) - The openFDA system user community will engage in a robust interactive discussion and provide feedback to FDA regarding openFDA's platform, application programming interfaces (APIs), downloadable harmonized datasets, and possible enhancements to the openFDA platform.

• New! June 21, 2016: FSMA Webinar: Final Rule on Mitigation Strategies To Protect Food Against Intentional Adulteration- 11:00 a.m. – 12:00 a.m. ET (please connect by 10:45 a.m.), registration not required

• New! June 21-22, 2016: The Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB) is holding a public meeting on topic areas related to incentives for the development of vaccines, diagnostics, and therapeutics, the environment and antibiotic-resistance (Washington, DC and webcast). There will also be a presentation regarding FDA Guidance for Industry #213, New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals (PDF, 115 KB). Register to attend in-person by June 18, 2016.

• June 30, 2016: Public Workshop - Clinical Trial Design Considerations and Laboratory Testing Technologies for Malaria Drug Development (Silver Spring, MD) (Federal Register notice)

• New! July 15, 2016: HHS Summit to Accelerate Zika Diagnostics Development (Washington, DC)
• July 18-19, 2016: Medical Management of Radiation Casualties: Where Research and Usage Meet  (Rockville, MD), hosted by the Radiation Injury Treatment Network and the National Institute of Allergy and Infectious Diseases (NIAID)

• New! July 18-19, 2016: Public Workshop - Facilitating Antibacterial Drug Development for Patients With Unmet Need and Developing Antibacterial Drugs That Target a Single Species Media (Silver Spring, MD)

View more events on the frequently updated MCMi News and Events page

Guidance and information for industry:

• Draft Guidance - Use of Electronic Health Record Data in Clinical Investigations (PDF, 247 KB)  - The draft guidance aims to facilitate use of electronic health record (EHR) data in clinical investigations and to promote the interoperability of EHRs and electronic systems supporting the clinical investigation. Comment by July 18, 2016.

• Statement from FDA Commissioner Robert Califf, M.D. on the release of the final individual patient expanded access form (Form FDA 3926, PDF, 88 KB) - also see Expanded Access to Investigational Drugs for Treatment Use Q&A (PDF, 180 KB) and Charging for Investigational Drugs Under an IND Q&A (PDF, 87 KB) - more about Expanded Access (June 2, 2016)

How to submit comments

In case you missed it:

• FDA grant opportunity - Strengthening Partnerships with State Legislatures to Promote the Safety of FDA Regulated Products and Advance Public Health. Application closing date isJuly 2, 2016.

• CDC is soliciting nominations for membership on the Clinical Laboratory Improvement Advisory Committee (CLIAC) and requesting suggested topics to be considered for future Committee deliberation. Nomination materials are due August 1, 2016.

• FDA issues final food defense regulation - On May 26, 2016, FDA finalized a new food safety rule under the landmark, bipartisan FDA Food Safety Modernization Act (FSMA) that will help to prevent wide-scale public health harm by requiring companies in the United States and abroad to take steps to prevent intentional adulteration of the food supply. While such acts are unlikely to occur, the new rule advances mitigation strategies to further protect the food supply. More about the final rule

• From HHS - Proactive Efforts by U.S. Federal Agencies Enable Early Detection of New Antibiotic Resistance (May 26, 2016)

• In May 2016, BARDA, CDC, NIH, and FDA signed a Memorandum of Understanding for development of innovative technologies to identify antimicrobial-resistant bacteria. This agreement provides a framework for coordination and collaborative efforts to spur innovation in the development of diagnostic devices that would be of great clinical and public health utility in combating the development and spread of bacteria that are resistant to antimicrobial drugs.

• In April 2016, NIH, the U.S. Department of Agriculture Animal and Plant Health Inspection Service (APHIS), and FDA signed a Memorandum of Understanding to set forth a framework for reciprocal cooperation which will assist each agency in meeting its responsibilities in promoting proper laboratory animal care and welfare.