|Course designed for researchers who conduct studies to support approval under the Animal Rule|
|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|
- January 8, 2018: Webinar for industry - CLIA Waiver Applications Draft Guidance Documents, 3:00 - 4:30 p.m. ET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|
More: MCM-Related Guidance by Date
- 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)
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