Search Results for IVDs

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Diagnostics: Bipartisan Duo Offers Bill to Alter Regulations By Zachary Brennan - Published 27 March 2017

The ongoing overhaul of diagnostic and lab-developed test (LDT) regulations turned another corner last week, with Reps. Larry Bucshon, M.D. (R-IN) and Diana DeGette (D-CO) releasing a discussion draft of a bill that would offer a new direction for the US Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS).

Categories: News, US, FDA, Government affairs, In vitro diagnostics, Medical Devices, Postmarket surveillance, Research and development

Tags: diagnostics, IVDs, IVCT, in vitro clinical test, LDT, lab-developed test

Illumina, Genentech and BIO Weigh in on FDA Draft Guidance on Companion Diagnostics By Zachary Brennan - Published 18 October 2016

The six public comments on the US Food and Drug Administration’s (FDA) draft guidance on companion diagnostics were mostly positive, with Genentech calling the draft “crucial for the advancement of personalized medicine,” while Illumina said it was “worth the wait,” though all commenters expressed interest in more clarity from FDA.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Combination products, Compliance, Drugs, Government affairs, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: companion diagnostics, IVDs, personalized medicine, Illumina, Genentech, AstraZeneca, BIO

FDA Offers New Draft Guidance on How to Co-Develop IVDs, Therapeutics By Zachary Brennan - Published 14 July 2016

The age of precision medicine, with treatments targeted to specific patients based on a companion test identifying the need for such a treatment, is pushing the US Food and Drug Administration (FDA) to release new and more detailed draft guidance on how companies can co-develop a therapeutic alongside what the agency is calling an in vitro companion diagnostic device, or IVD companion diagnostic.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Government affairs, In vitro diagnostics, Manufacturing

Tags: precision medicine, companion diagnostics, IVDs, therapeutic, genetic tests

EU Council and Parliamentary Committees Sign Off on New Medical Device, IVD Regulations By Zachary Brennan - Published 15 June 2016

The European Council's Permanent Representatives Committee and the European Parliament’s Environment and Health Committee on Wednesday endorsed the agreement reached on the continent’s new medical device and in vitro diagnostic (IVD) regulations, a day after the draft versions of the texts were released.

Categories: News, Europe, EC, EMA, Clinical, Crisis management, Government affairs, Medical Devices, Quality

Tags: medical device and IVDs in EU, new device regulations, European Commission medical device regulations

FDA Lays Out New Areas of Interest for Training Device Review Staff By Zachary Brennan - Published 13 November 2015

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Friday invited industry, academia and health care facilities to participate again in a program that helps train medical device review staff.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Combination products, Due Diligence, Government affairs, In vitro diagnostics, Manufacturing, Medical Devices, Quality, Regulatory intelligence, Regulatory strategy

Tags: CDRH, IVDs, medical device training, device manufacturing

House Committee Floats Draft Bill for New FDA Regulations of In Vitro Clinical Tests By Zachary Brennan - Published 23 October 2015

In advance of a hearing next Thursday, the House Energy & Commerce Committee has released a draft discussion bill that would set up new regulations for in vitro clinical tests.

Categories: News, US, FDA, Government affairs, In vitro diagnostics, Regulatory intelligence, Regulatory strategy

Tags: LDTs, lab-developed tests, IVDs, in vitro diagnostics, in vitro clinical tests, diagnostics

Types of In Vitro Diagnostics: Clearing Up the Confusion By Heidi Hancock Strunk, RAC - Published 16 January 2015

In vitro diagnostics: It is easy to get lost in a seemingly foreign language of acronyms for IVDs—ASRs, RUOs, LDTs and more. Can a company explain the differences between ASRs and LDTs—not to mention RUOs, IUOs, “home brew” tests and companion IVD diagnostics? An overview of the various types of IVDs.

Categories: Features, US, FDA, In vitro diagnostics

Tags: FDA, in vitro medical devices, IVDs, FDA guidance, GPRs, CLIA

FDA Provides Some Clarity to Complex Regulatory Environment for Molecular Diagnostics By Alexander Gaffney, RAC - Published 10 November 2014

A new guidance document issued by the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) aims to clarify the regulatory processes by which certain molecular diagnostic devices are approved or cleared by federal regulators.

Categories: News, US, CDRH, In vitro diagnostics, Medical Devices, Submission and registration

Tags: Molecular Diagnostic Instruments, Guidance, Final Guidance, Molecular Diagnostics, IVDs

Regulatory Perspectives on Companion Diagnostics By Philipp Novales-Li, DMedSc, PhD, DPhil, RAC - Published 09 October 2013

Companion diagnostics offer a revolutionary approach for redefining the traditional fields of pharmacology and disease diagnostics. This article covers recent developments in regulatory science related to companion diagnostics.

Categories: Features, FDA, Medical Devices

Tags: IVDs, companion diagnostics

Draft IVD Proposal Would Strengthen Clinical Testing Requirements By Alexander Gaffney, RF News Editor - Published 17 April 2013

Categories: EC

Tags: IVDs, Proposal, ENVI, Legislation, Latest News, EU, medical device

New Guidance on Molecular Diagnostics Calls for MDR Reporting for Some Unapproved Devices By Alexander Gaffney, RF News Editor - Published 08 April 2013

Categories: US, FDA, CBER, CDRH

Tags: IVDs, draft guidance

Brazil: Regulators Partner With Government to Advance Regulatory Science By Ansis Helmanis, RegLink - Published 10 September 2012

Categories: Regulatory Update, Anvisa, Technology

Tags: IVDs, CNPq, regulatory science