MCMi Professional Development Activities > Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories

MCMi Professional Development Activities > Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories

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Course designed for researchers who conduct studies to support approval under the Animal Rule

This popular course offers a unique opportunity for the regulatory and scientific communities to discuss complex issues in an interactive environment, and identify and share best practices for ensuring data quality and integrity in BSL-4 facilities. The 2018 course will take place April 23-27, 2018 in Bethesda, Maryland. Registration will open January 8, 2018. Early registration is recommended, as this course quickly fills to capacity. FDA sponsors this course as part of our work to advance the development and availability of medical countermeasures; there is no registration cost. Related information Information about this course, including FAQs and how to register Poster: Measuring the Success of the UTMB-FDA Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories (PDF, 833 KB), presented in August 2017   Animal Rule information

Image: Course attendees participate in lectures and hands-on activities during previous courses. More course photos are available on Flickr.

Predictive Toxicology Roadmap

FDA's Toxicology Working Group outlined a new plan (PDF, 2.2 MB) to expand the agency's predictive toxicology toolbox, and reduce reliance on animal testing for tox studies. Learn more

Events January 8, 2018: Webinar for industry - CLIA Waiver Applications Draft Guidance Documents, 3:00 - 4:30 p.m. ET  New! January 10, 2018: Webinar for industry  - Technical Considerations for Additive Manufactured Medical Devices, 1:00 - 2:30 p.m. ET New! January 11, 2018: Antimicrobial Drugs Advisory Committee public meeting (Hyattsville, MD) - The committee will discuss new drug application (NDA) 210693, ciprofloxacin dispersion for inhalation, sponsored by Aradigm Corp., for the proposed indication of treatment of non-cystic fibrosis bronchiectasis patients with chronic lung infections with Pseudomonas aeruginosa. New! January 30-31, 2018: Public workshop - Fostering Digital Health Innovation: Developing the Software Precertification Program (Bethesda, MD and webcast) - register by 4:00 p.m. ET January 18, 2018  February 7-8, 2018: Tenth Annual Sentinel Initiative Public Workshop (Bethesda and Silver Spring, MD, and webcast) - The stakeholder community will discuss a variety of topics on active medical product surveillance. To attend in-person or via webcast, register here for Day 1 and/or here for Day 2by February 6, 2018. To attend both days, please register separately for each.

Information for industry FDA's Center for Drug Evaluation and Research (CDER) invites pharmaceutical companies interested in participating in the 2018 CDER Office of Pharmaceutical Quality (OPQ) Staff Experiential Learning Site Visit Program to submit a proposal by February 2, 2018. FDA announced the establishment of the Susceptibility Test  Interpretive Criteria website, which will help  to efficiently update susceptibility test interpretive criteria for antimicrobial drugs  when necessary for public health, and may  allow for more efficient development and evaluation  of antimicrobial susceptibility test (AST) devices. Also see FDA launches new tool for sharing information that allows doctors to better manage antibiotic use; improve patient care and 21st Century Cures Act (December 13, 2017) FDA Voice - Advancing Policies to Promote Safe, Effective MedTech Innovation - Early in the coming year, FDA’s Center for Devices and Radiological Health (CDRH) intends to advance several important new regulatory policy initiatives to further modernize the medical devices program and continue to foster new medtech innovation. FDA has established a docket where interested persons may comment on the priority of topics for guidance, provide comments and/or propose draft language for those topics, suggest topics for new or different guidance documents, comment on the applicability of guidance documents that have issued previously, and provide any other comments that could benefit the CDRH guidance program and its engagement with stakeholders. Submit comments by February 12, 2018. Also see CDRH FY 2018 Proposed Guidance Development and Focused Retrospective Review of Final Guidance (December 11, 2017) Draft guidance - Pediatric Rare Diseases: Collaborative Approach for Drug Development Using Gaucher Disease as Model  (PDF, 262 KB) - comment by February 5, 2018 - also see FDA recommends new, more efficient approach to drug development for rare pediatric diseases (December 7, 2017) Guidance - Technical Considerations for Additive Manufactured Medical Devices (PDF, 619 KB) - FDA is the first in the world to provide a comprehensive technical framework to advise manufacturers creating medical products on 3D printers. On January 10, 2018, FDA will hold a webinar for industry to review this guidance and answer questions. Also see Statement by FDA Commissioner Scott Gottlieb, MD, on FDA ushering in new era of 3D printing of medical products, and 3D Printing of Medical Devices (December 4, 2017) More: MCM-Related Guidance by Date

In case you missed it FDA food defense experts discuss what the agency is doing to protect our food supply from intentional adulteration, such as acts of terrorism (December 7, 2017) CDER Researchers Explore the Promise and Potential of 3D Printed Pharmaceuticals - also see The 3Rs of 3D Printing: FDA's Role (December 11, 2017) FDA's Center for Biologics Evaluation and Research (CBER) is recruiting for several scientist positions: senior staff fellow/visiting scientists for influenza vaccines and vector-borne diseases, and a staff fellow(interdisciplinary scientist). Apply by January 15, 2018.  FDA Releases Annual Summary Report on Antimicrobials Sold or Distributed in 2016 for Use in Food-Producing Animals - The 2016 report shows that antimicrobial sales decreased from 2015 to 2016, with domestic sales and distribution of all antimicrobials decreasing by 10 percent and domestic sales and distribution of medically important antimicrobials decreasing by 14 percent. In previous years (between 2009 and 2015), overall sales volumes increased annually. (December 7, 2017) Updates on two Zika vaccine candidates from NIH: Gene-based Zika vaccine is safe and immunogenic in healthy adults - vaccine developed by NIH scientists shows promise in Phase 1 testing, and Trials show inactivated Zika virus vaccine is safe and immunogenic - results support further clinical development