NOTICIAS

DATA INTEGRITY REFERENCES

.-EMA: Questions and answers: Good manufacturing practice - Data Integrity Section .-FDA: FDA Data Integrity Guidance .-MHRA: MHRA Data Integrity Definitions and Guidance .-PIC/S: PIC/S Guidance .-WHO: WHO...

FDA Announces Streamlined Review Pathway for DTC Genetic Tests

At a time when people are more aware of and engaged in their health care than ever before, genetic risk testing can provide helpful information about an individual’s predisposition for certain diseases and conditions. These tests can prompt consumers to be more...

FDA to Recognize 8 EU Regulators to Conduct GMP Inspections

The U.S. Food and Drug Administration has determined the agency will recognize eight European drug regulatory authorities as capable of conducting inspections of manufacturing facilities that meet FDA requirements. The eight regulatory authorities found to be capable...

Breakthrough Devices Program

The Breakthrough Devices Program is a voluntary program for certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. This program is intended to help patients have more...

FDA Guidances on Device User Fees, MDUFA IV Goals & Pre-Submissions

The FDA has issued new  guidances for  medical device makers : User Fee Guidances: User Fees and Refunds for Premarket Notification Submissions (510(k)s) User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications User Fees and...

Revised RMP template mandatory as of 31 March 2018

Revised RMP template and transitional arrangements On 30 March 2017, EMA published the second revision of the RMP template, which marketing authorisation holders and applicants can use for all RMP submission as of 31 March 2017. Its use for all RMP submissions...

Unparalleled access to clinical data – one year on

Over 3,000 clinical documents published, 3,600 registered users and positive stakeholder feedback One year ago today, the European Medicines Agency (EMA) became the first regulatory authority to give open access to clinical data submitted by companies in support of...

Updated FDA Manual : Inspection Protocols

The US Food and Drug Administration (FDA) published its 2017 version of a chapter of its investigations operations manual on establishment inspections DOWNLOAD  Updated FDA Manual : Inspection...

Format and Content of a REMS Document

This guidance provides updated recommendations for the format and content of a risk evaluation and mitigation strategy (REMS) document for a prescription drug product, including a biological drug product.  A REMS document, which is part of a REMS that is required by...

Supplier and Supply Chain Qualification and Supply Chain Verification

Roadmap for Global Medical Product Integrity and Supply Chain Security Manufacturing Practices Work Group   The new toolkit, born out of a five-year collaborative project that actually took four years to complete, brings expertise from the US Pharmacopeial Convention...

Novo curso : Boas Práticas de Fabrico GMP 2018

CONDUZIDO PELA ESPECIALISTA DRª FERNANDA RALHA . Diretora.Direcção de Inspeção e Licenciamento. INFARMED Os Estados-Membros devem adotar e publicar, até 31 de março de 2018, as disposições legislativas, regulamentares e administrativas necessárias para dar cumprimento...

Countdown to launch of new EudraVigilance System

Final preparations for change-over to new system underway for go live date on 22 November 2017 On 22 November 2017, the European Medicines Agency (EMA) will launch a new and improved version of EudraVigilance, the European information system of suspected adverse...

Publicada a nova legislação EU GMP

A Comissão Europeia publicou no Jornal Oficial da União Europeia dos novos documentos : Directive 2017/1572 on principles and guidelines of Good Manufacturing Practice (GMP) for medicinal products for human use to supplement Directive 2001/83/EG (for advanced therapy...

FDA improves access to reports of adverse drug reactions

FDA improves access to reports of adverse drug reactions New online tool makes it easier for users to search the FDA Adverse Event Reporting System The U.S. Food and Drug Administration today launched a new user-friendly search tool that improves access to data on...

EY MEDTECH REPORT 2017

Ernst & Young new report on how the global medical technology (medtech) industry 

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