Course registration open

Achieving Data Quality and Integrity in Maximum Containment Laboratories

April 24-28, 2017 - National Institutes of Health, Bethesda, Maryland

FDA and the University of Texas Medical Branch, Galveston National Laboratory collaborate to provide an annual training course in how to meet Good Laboratory Practice (GLP) requirements in high and maximum biocontainment security level (BSL) laboratory facilities.

The course includes expert lectures and hands-on laboratory activities conducted in BSL-2 and BSL-4 training laboratories to emphasize the differences between biosafety levels, and the complexity of conducting laboratory activities in a BSL-4 environment.

FDA welcomes participants from government, industry, and academia, including international participants. Register by noon February 24, 2017.

Related information

How to request an invitation
More about the course, from UTMB
About MCMi professional development activities

Emergency Use Guidance

On January 13, 2017, FDA published the guidance Emergency Use Authorization of Medical Products and Related Authorities.

This guidance explains FDA’s general recommendations and procedures applicable to the authorization of the emergency use of certain medical products following the enactment of the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA). It addresses Emergency Use Authorizations (EUAs) and other MCM emergency use authorities (e.g., emergency dispensing orders and expiry dating extensions) provided by PAHPRA.

This finalizes the draft guidance, Emergency Use Authorization of Medical Products and Related Authorities (April 2016) and replaces two guidance documents: Emergency Use Authorization of Medical Products (July 2007) and Emergency Use Authorization Questions and Answers (April 2009).

Related information

Printable PDF of the guidance (288 KB)
Federal Register notice (January 13, 2017)
Summary of process for EUA issuance (graphic)
Summary of PAHPRA's MCM provisions

EUA amendments

January 12, 2017 - CDC Trioplex Real-time RT-PCR Assay (Trioplex rRT-PCR) (CDC)
January 7, 2017 - xMAP® MultiFlex™ Zika RNA Assay (Luminex Corporation)
January 6, 2017 - RealTime Zika Assay (Abbott Molecular Inc.)

More information about EUAs and amendments is available on the FDA Zika virus response updates page. Also see the latest CDC Zika Laboratory Guidance, implemented in November 2016.

Emergency Use Authorization (EUA) banner

Guidance and information for industry

FDA is reopening the comment period for the notification of public hearing, published in the Federal Register on September 1, 2016, concerning our comprehensive review of regulations and policies governing manufacturer communications regarding unapproved uses of approved or cleared medical products. Submit comments by April 19, 2017. (January 19, 2017)
Draft guidance (biosimilars) - Considerations in Demonstrating Interchangeability With a Reference Product Guidance for Industry (PDF, 229 KB) - comment by March 20, 2017 (January 18, 2017)
Final guidance - Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus (PDF, 99 KB) - notifies blood establishments that FDA has determined Ebola virus to be a transfusion-transmitted infection (TTI) and provides blood establishments that collect blood and blood components for transfusion or further manufacture, including Source Plasma, with FDA recommendations for assessing blood donor eligibility, donor deferral, and blood product management in the event that an outbreak of Ebola virus disease (EVD) with widespread transmission occurs in at least one country. (January 10, 2017)
FDA is reclassifying antigen based rapid influenza virus antigen detection test systems intended to detect influenza virus directly from clinical specimens that are currently regulated as influenza virus serological reagents from class I into class II with special controls and into a new device classification regulation. This order is effective February 13, 2017.

How to comment on current FDA draft guidances

Events

New! January 24, 2017: Webinar - learn about the guidance Collection of Race and Ethnicity Data in Clinical Trials-Guidance for Industry and FDA Staff (PDF, 896 KB) - 12:00 - 1:00 p.m. ET - hosted by the FDA Office of Minority Health - information and registration
January 25, 2017: Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PAC-CARB) meeting (Washington, DC and webcast) - register to attend in-person by January 20, 2017
February 2, 2017: Ninth Annual Sentinel Initiative Public Workshop (Washington, DC and webcast) - register before February 2, 2017 (in-person attendance is at capacity; a webcast will be available)
February 8-9, 2017: Public workshop - Identification and Characterization of the Infectious Disease Risks of Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps) (College Park, MD) Attendance for this workshop is in-person only, and seating is limited - register by February 6, 2017
New! March 9, 2017: Vaccines and Related Biological Products Advisory Committee (Rockville, MD and webcast) - the committee will meet in open sessionto discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2017-2018 influenza season
New! April 6, 2017: Public workshop - Emerging Tick-Borne Diseases and Blood Safety (Bethesda, MD) - to discuss tick-borne pathogens that continue to emerge as threats to blood safety, the effectiveness of current and potential mitigation strategies, and the general approach to decision making on blood safety interventions - register by March 23, 2017

In case you missed it

FDA Requests Comments on Documents Related to Certain Biotechnology and Mosquito-related Products - FDA is requesting public comment on a draft revised guidance (PDF, 200 KB) on the regulation of animals with intentionally altered genomic DNA, including animals produced through the use of genome editing and genetic engineering, and a draft guidance (PDF, 74 KB) that clarifies which mosquito-related products FDA regulates and which such products EPA regulates, regardless of whether these mosquito-related products are developed using biotechnology. Also see Oxitec Mosquito; Q&A on FDA Regulation of Intentionally Altered Genomic DNA in Animals; and FDA Voice: FDA’s Science-based Approach to Genome Edited Products (January 18, 2017)
From HHS (Common Rule) - Final rule enhances protections for research participants, modernizes oversight system - The U.S. Department of Health and Human Services and 15 other federal agencies today issued a final rule to update regulations that safeguard individuals who participate in research. Most provisions in the new rule will go into effect in 2018. (January 18, 2017)
Consumer updates: Is It Really 'FDA Approved?' (January 17, 2017) and FDA encourages more participation, diversity in clinical trials (January 11, 2017)
From HHS - BARDA-supported Zika vaccine candidate enters clinical trial (January 9, 2017)