NOTICIAS

Data Integrity and Compliance With Drug CGMP

FDA expects that all data be reliable and accurate (see the “Background” section). CGMP regulations and guidance allow for flexible and risk-based strategies to prevent and detect data integrity issues. Firms should implement meaningful and effective strategies to...

Biomarker Qualification: Evidentiary Framework Guidance for Industry

The evidentiary framework described in this guidance identifies the recommended components  of a biomarker development program, including determining the type and level of evidence  sufficient to support qualification, and addresses how these components interrelate to...

FRAMEWORK FOR FDA’S REAL-WORLD EVIDENCE PROGRAM

FDA’s RWE Program will be multifaceted. It will involve demonstration projects, stakeholder engagement, internal processes to bring senior leadership input into the evaluation of RWE and promote shared learning and consistency in applying the framework, and...

Data Management Fundamentals for Your Next Clinical Trial

Data Management Fundamentals for Your Next Clinical Trial

Data is the most crucial asset in any clinical trial and is used to ultimately drive the decision-making process related to the development candidate. Therefore, for any sponsor, paying close attention to the data management aspects of clinical operations should...

Optimizing Standards for Regulatory Use

Optimizing Standards for Regulatory Use

Standards play a significant role in the design, production, post-production and regulation of medical devices throughout their lifecycle. Important tools for conformity assessment, standards facilitate and support innovation and help ensure that devices are safe and...

Reflection paper on the qualification of non-genotoxic  impurities

Reflection paper on the qualification of non-genotoxic impurities

The core ICH quality guidelines addressing qualification of NGI are ICH Q3A and Q3B. These guidelines  state that qualification is the process of acquiring and evaluating data that establishes the biological  safety of an individual impurity or a given impurity...

Impact of IVDR on  manufacturers of medical devices

Impact of IVDR on manufacturers of medical devices

This Factsheet is aimed at manufacturers of medical devices. For a general overview of the impact of the In-Vitro Medical Devices Regulation (IVDR) on manufacturers see the Factsheet for manufacturers of in-vitro diagnostic medical devices. Factsheet for manufacturers...

EMA  Guideline on GVP Considerations for Pediatric Populations

EMA Guideline on GVP Considerations for Pediatric Populations

New legislation for pharmacovigilance applies in the European Union (EU) since July 2012, and to support its implementation, a set of guidelines for the conduct of pharmacovigilance in the EU has been developed which, as they have been adopted, replaced the previous...

Meta-Analyses of Randomized Controlled Clinical Trials

This document provides guidance to applicants submitting investigational new drug applications (INDs), new drug applications (NDAs), biologics license applications (BLAs), or supplemental  applications on the use of meta-analyses of randomized controlled clinical...

EU guidance for new Medical Device Regulation (MDR)

EU guidance for new Medical Device Regulation (MDR)

With the coming into force of the Medical Device Regulation (MDR) in 2020, the guidelines 93/42/EEC and 90/385/EEC, which have regulated the field of medical devices so far, will become invalid. But what is going to change? And how are these changes to be implemented?...

MDR and IVDR implementing measures rolling plan

MDR and IVDR implementing measures rolling plan

The European Commission (EC) issued a working plan on Wednesday for the implementation of the new EU medical device and in vitro diagnostics regulations (MDR and IVDR). The EC’s working plan describes the legal basis, the expected adoption timelines and the current...

Guidance on UDI for systems and procedure packs

Guidance on UDI for systems and procedure packs

New regulations Guidance document to assist stakeholders in implementing the Medical Devices Regulations. MDCG 2018-3 Guidance on UDI for systems and procedure packs MDCG 2018-4 Annex: UDI database Definitions/Descriptions and formats of the UDI core elements for...

The Essential Guide To Electronic Informed Consent

The Essential Guide To Electronic Informed Consent

This e-book has been designed as an introduction to electronic informed consent (eConsent) in clinical trials for those researchers considering making the switch from traditional paper-based processes. The Essential Guide To Electronic Informed Consent

THE RACE TO EU MDR COMPLIANCE

THE RACE TO EU MDR COMPLIANCE

An industry survey conducted by KPMG and the Regulatory Affairs Professionals Society (RAPS) found little familiarity with the European Union’s new Medical Device Regulation and its requirements that take full effect in May 2020. read the survey  :THE RACE TO EU MDR...

Perguntas e respostas sobre o sistema dos dispositivos de segurança

Este documento pretende informar sobre o entendimento do INFARMED, I.P. relativamente às questões mais colocadas pelas entidades sobre a implementação dos dispositivos de segurança nas embalagens de medicamentos de usos humano. Download: Perguntas e respostas sobre o...

Postapproval Changes to Drug Substances Guidance for Industry

This guidance provides recommendations to holders of approved new drug applications (NDAs), abbreviated new drug applications (ANDAs), new animal drug applications (NADAs), and abbreviated new animal drug applications (ANADAs) and holders of drug master files...

Medicamentos biossimilares na UE

Medicamentos biossimilares na UE

The European Medicines Agency (EMA) and the European Commission have published additional information material on biosimilar medicines, as part of their ongoing collaboration to improve understanding of biosimilars across the European Union (EU). A biosimilar...

Postapproval Changes to Drug Substances Guidance for Industry

This guidance provides recommendations to holders of approved new drug applications (NDAs), abbreviated new drug applications (ANDAs), new animal drug applications (NADAs), and  abbreviated new animal drug applications (ANADAs) and holders of drug master files...

FDA´s final Guidance on Elemental Impurities in Drug Products

The U.S. Food and Drug Administration, FDA, recently published its final guidance on Elemental Impurities in Drug Products which finalizes the draft guidance issued July 1, 2016. The guidance provides recommendations regarding the required documentation related to the...

Principles of Labeling for Medical Devices and IVD Medical Devices

Principles of Labeling for Medical Devices and IVD Medical Devices

The purpose of this IMDRF guidance is to provide globally harmonized labeling principles for medical devices and IVD medical devices and support the IMDRF Essential Principles of Safety  and Performance. Specifically, this document provides guidance on the content of...

Unique Device Identification system (UDI system) Application Guide

Unique Device Identification system (UDI system) Application Guide

The IMDRF UDI Guidance (IMDRF/WG UDI/N7Final:2013) provides a framework for the regulatory authorities that intend to develop their UDI systems in a globally harmonized approach. This UDI system Application Guide is to be used as a supplement to the IMDRF UDI Guidance...