Post

TEST
Home > FDA Publishes Final Guidance for Industry on Nanomaterials in Drug Products

FDA Publishes Final Guidance for Industry on Nanomaterials in Drug Products

The U.S. Food and Drug Administration (FDA) has published the final guidance document for industry “Drug Products, Including Biological Products, that Contain Nanomaterials” . FDA states that the guidance applies broad array of FDA-regulated products such as human drug products, including those that are biological products, in which a nanomaterial is present in the finished dosage form. The guidance discusses both general principles and specific considerations for developing drug products containing nanomaterials through abbreviated pathways, as well as considerations for quality, nonclinical, and clinical studies as they relate to drug products containing nanomaterials throughout product development and production.

M.ERA-Net Call 2022 launched – Submit your Proposals now

On 15 March 2022, the current M.ERA-Net call for proposals 2022 was published. More than 30 funding organisations are participating with a total budget of around 25 million euros. The deadline for the submission of pre-proposals is 15 June 2022.

The Call 2022 includes the following thematic areas:

  • Materials for energy
  • Innovative surfaces, coatings and interfaces
  • High performance composites
  • Functional materials
  • New strategies for advanced material-based technologies in health applications
  • Materials for electronics

The transnational projects funded by M-ERA.NET are expected to contribute to clean energy-related applications and battery technologies by improving the efficiency of production processes, reducing the usage of materials and energy resources and by improving materials properties such as durability. New approaches to health applications with the focus on advanced materials and coatings will also be addressed. As a new topic, materials for electronics is included.

 

Deadlines

  • 15.06.2022 – Submission Pre-Proposals
  • 17.11.2022 – Submission Full proposals
NanoHarmony Project logo

NanoHarmony Webinar series on Improving the OECD Test Guidelines

Are you interested in contributing to the development of OECD test guidelines ,but don’t know where to start? Or do you already contribute to this process, but want to know how to avoid delays in your methods being adopted? If soso, then we’d like to hear from you in our new webinar series.

During the first half of 2022, the NanoHarmony Project (https://nanoharmony.eu/) is running a webinar series covering the journey of a test guideline (TG) through the OECD process to be able to understand the challenges and barriers that need to be addressed at each stage. The webinars will all be interactive with the aim of gathering input from all stakeholders involved in the OECD test guideline development process, along with those that are interested in the use of TGs, as well as researchers who are looking to develop their outcomes into new TGs.

The webinars will cover the different phases that an OECD TG progresses through during its journey from a science based initial idea through to use in industry to fulfil regulatory obligations. The webinars will bring together a range of presenters involved with the relevant TG phase to discuss the barriers and learning lessons so that proposals can be made to improve the development process and make it more efficient.

All stakeholders are invited to attend to give their opinions and to help agree consensus on the barriers and ways of improving the test guideline process that can be actioned as part of the legacy of the NanoHarmony project. The webinars will be highly interactive and attendees will have the opportunity of sharing their experiences, thoughts and suggestions.

The webinars will be held every 3-4 weeks starting from 1 March 2022 and stakeholders are able to attend the most relevant phases that they are interested in or indeed the whole series.

 

1st Webinar “Phase 4 Using Test Guidelines” – 01.03.2022

Registration for the online event via https://www.eventbrite.ca/e/nanoharmony-improving-the-oecd-test-guidelines-process-using-tgs-tickets-261660452457

 

Survey launched by ISO TC 229 Advanced Emergent Material Terminology Study Group

ISO Technical Committee 229  ISO TC 229 has formed an study group on advanced and emergent materials to help identify and resolve (where appropriate) terminology issues involving innovations related to nanotechnologies. As part of this effort the study group is seeking input from internal and external stakeholders, and subject matter experts to ensure that any term considered for development adequately addresses the broader communities.  For awareness, the following are the original terms of reference for the Study Group:

  • Evaluate the need for terminology surrounding advanced and emerging materials dealing with nanotechnology
  • Evaluate the need for additional terms to clarify differences between variations in the use of terms related to advanced materials.
  • Discuss with other TC/229 working groups to identify needs in terminology and liaise with other relevant organizations as needed

 

Take part in the Survey via    https://forms.office.com/pages/responsepage.aspx?id=IP-naC-BOEeQ6gsQUYRvdOw-Vfgs1wpHpf_QAMxMfB5UMEpSM0tJNUlHTUE4NkE3R01YUE5XMDhYTy4u

Gracious Guidance Documents on Grouping & Read-Across for nanoforms now published!

The H2020 EU-project GRACIOUS has developed two Guidance Documents explaining how users from industry, regulation and academia can use the GRACIOUS Framework for grouping and read-across of nanomaterials/nanoforms.

 

The first is a detailed GRACIOUS Guidance Document which provides users with a detailed step-by-step guidance on how to use the Framework. This document also includes hands-on examples and practical tips for users.

The second is a Guidance in a Nutshell. This is a simplified short version of the detailed document. It is intended to be an introduction to both the concepts used in the GRACIOUS Framework and the main steps the user will need to address during the use of the Framework.

 

Further details on the project, the achievements and outputs can be accessed via https://www.h2020gracious.eu/

 

Skip to content