NOTICIAS

Total Product Lifecycle Considerations for Generative AIEnabled Devices

Total Product Lifecycle Considerations for Generative AIEnabled Devices

While interest in generative artificial intelligence (GenAI) tools across the health care sector has expanded rapidly, there remain open questions on the approach to regulating GenAI-enabled products that may fall within FDA’s jurisdiction, including, but not limited...

Revision of the Cosmetic Products Regulation

Revision of the Cosmetic Products Regulation

Consumers are exposed to chemicals present in cosmetics. Any cosmetic product sold on the EU market must comply with the rules set up by Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (the Cosmetic...

ARTIFICIAL INTELLIGENCE IN MEDICAL DEVICES

ARTIFICIAL INTELLIGENCE IN MEDICAL DEVICES

This questionnaire was prepared in accordance with the request of MDCG, published in the Medical Device Coordination Group (MDCG) position paper in August 2022, for notified bodies to develop common guidance for manufacturers to assist them in the application phase...

First Draft of the General-Purpose AI Code of Practice published

First Draft of the General-Purpose AI Code of Practice published

Independent experts present the first draft of the General-Purpose AI Code of Practice, which will be discussed with around 1000 stakeholders next week. The AI Office is facilitating relevant AI Act understanding with dedicated questions and answers for stakeholders....

PROMOTIONAL REVIEW : Mais uma edição marcada pelo sucesso

PROMOTIONAL REVIEW : Mais uma edição marcada pelo sucesso

Ontem, tivemos o prazer de realizar uma nova edição da formação exclusiva da FORMIVENTOS  sobre o PROMOTIONAL REVIEW de Medicamentos :  COMPLIANCE & BEST PRACTICES, com uma visão global da legislação ,  para consolidar e rever casos específicos da revisão de...

EIC 2025 work programme

EIC 2025 work programme

  The European Commission adopted the 2025 work programme of the European Innovation Council. It opens funding opportunities worth over €1.4 billion for strategic technologies and scaling up companies. The European Innovation Council and SMEs Executive Agency...

FDA drafts guidance on drug interaction labeling

FDA drafts guidance on drug interaction labeling

The US Food and Drug Administration (FDA) has released a new draft guidance describing what should and should not be included in the Drug Interactions (DIs) section for human prescription drug and biological product labeling as well as how drug interaction information...

European medicines agencies network strategy to 2028

European medicines agencies network strategy to 2028

EMA and the Heads of Medicines Agencies (HMA) have published their draft joint EU network strategy to 2028 for an eight-week public consultation. This is a review and update to the original five-year strategy, which was developed to cover the period 2021 to 2025...

EUDAMED user guide Guidelines on Data Exchange with EUDAMED

EUDAMED user guide Guidelines on Data Exchange with EUDAMED

The purpose of this document is to help Competent Authorities, Notified Bodies, as well as all Economical Operators (Manufacturers, Authorised Representatives, Importers, and System/Procedure Pack Producers) in assessing the most cost-efficient solution for their...

Guidance for best practices for clinical trials

Guidance for best practices for clinical trials

This document responds to requests by the World Health Assembly to the Director-General in resolution WHA75.8 (2022) on strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination to identify...

IMDRF Document Implementation Report

IMDRF Document Implementation Report

The International Medical Device Regulators Forum (IMDRF) is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF) and aims...

New FDA Guidance on Biocompatibility Testing of Medical Devices

New FDA Guidance on Biocompatibility Testing of Medical Devices

Biocompatibility Testing of Medical Devices - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff September...

FDA GUIDANCE: STUDY DATA TECHNICAL CONFORMANCE GUIDE

FDA GUIDANCE: STUDY DATA TECHNICAL CONFORMANCE GUIDE

  This Document is incorporated by reference into the following Guidance Document(s): Guidance for Industry Providing Regulatory Submissions in Electronic SEPTEMBER 2024 This Guide provides technical recommendations to sponsors4 for the submission of animal and...