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Filtering on: "topics in vitro diagnostics"

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Medical Product Communications: Industry Seeks to Reform FDA Draft Guidances By Zachary Brennan - Published 21 April 2017

With a flood of new comments, pharmaceutical, biotech and medical device companies are seeking changes to two draft guidances explaining the US Food and Drug Administration's (FDA) evolving policies on industry communications with payers and claims that adhere to a drug's label.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, In vitro diagnostics, Labeling, Medical Devices

Tags: medical product communications, off-label promotion, payer communications

Asia Regulatory Roundup: India Looks to Reform Drug Pricing Legislation (18 April 2017) By Nick Paul Taylor - Published 18 April 2017

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CDSCO, CFDA, TGA, Biologics and biotechnology, Drugs, In vitro diagnostics, Medical Devices, Regulatory strategy

Tags: Asia regulatory roundup, India drug pricing, CFDA clinical trial, China drug regulations

Theranos Agrees to Two Year Ban, Refunds Every Arizonan Who Purchased a Blood Test By Zachary Brennan - Published 18 April 2017

As part of an agreement reached with Arizona attorney general Mark Brnovich, the medical device startup Theranos on Tuesday agreed to pay $4.65 million for about 1.5 million blood tests sold to more than 175,000 Arizonans.

Categories: News, US, Compliance, Crisis management, In vitro diagnostics, Medical Devices

Tags: Theranos, blood test, Arizona, CMS

BIO, AdvaMed Seek to Tweak FDA’s New Pre-Request Draft Guidance for Combo Products By Zachary Brennan - Published 17 April 2017

Industry groups BIO and AdvaMed are seeking some changes to the US Food and Drug Administration’s (FDA) guidance on requesting informal input on combination product designations.

Categories: News, US, CBER, CDER, CDRH, Biologics and biotechnology, Combination products, Drugs, In vitro diagnostics, Medical Devices, Quality, Regulatory intelligence, Regulatory strategy

Tags: BIO, AdvaMed, combination product guidance, pre-RFD program

FDA Identifies More Than 70 Class I Devices Now Exempt From 510(k) Requirements By Zachary Brennan - Published 12 April 2017

As part of its implementation of the 21st Century Cures Act, the US Food and Drug Administration (FDA) on Wednesday released a list of more than 70 Class I medical devices that are now exempt from premarket notification requirements.

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

Tags: 21 Century Cures, Class I devices, medical devices

IMDRF Offers New Guideline on Adverse Event Reporting By Zachary Brennan - Published 10 April 2017

As a way to improve the accuracy and capture of medical device adverse events, the International Medical Device Regulators Forum (IMDRF), a voluntary and global group of device regulators, on Monday published a new final guideline on a harmonized terminology for reporting such events.

Categories: News, Asia, Canada, Europe, US, IMDRF, Compliance, In vitro diagnostics, Medical Devices, Postmarket surveillance, Quality

Tags: adverse events for medical devices, IMDRF guideline, GHTF

FDA Approves First DTC Tests Evaluating Genetic Risk Information By Zachary Brennan - Published 06 April 2017

The US Food and Drug Administration (FDA) on Thursday authorized the first direct-to-consumer genetic health risk tests for 10 diseases and conditions.

Categories: News, US, CDRH, Clinical, In vitro diagnostics, Medical Devices

Tags: 23andMe, direct to consumer genetic tests, genetic tests, Alzheimer's, Parkinson's

EU Parliament Adopts New Medical Device, IVD Regulations By Michael Mezher - Published 05 April 2017

The EU's effort to overhaul the regulation of medical devices and in vitro diagnostics (IVDs) has cleared its final legislative hurdle after the European Parliament on Wednesday adopted the proposed regulations without amendment, voting down a proposal from the UK Independence Party to reject the regulations.

Categories: News, Europe, EC, In vitro diagnostics, Medical Devices, Postmarket surveillance, Submission and registration

Tags: MDR, IVDR, European Parliament

Failure to Reauthorize User Fee Programs Would Result in About 3,000 FDA Layoffs By Zachary Brennan - Published 04 April 2017

Representatives from the biotechnology, medical device and generic drug industries told members of the Senate Committee on Health, Education, Labor & Pensions on Tuesday that if the five-year user fee programs are not reauthorized, the US Food and Drug Administration (FDA) would likely see more than 3,000 job cuts.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, In vitro diagnostics, Medical Devices

Tags: user fees, PDUFA, BsUFA, MDUFA, GDUFA, AdvaMed, BIO, AAM

UK Triggers Brexit: What’s Next for the UK, MHRA and EMA? By Zachary Brennan - Published 29 March 2017

UK Prime Minister Teresa May on Wednesday set in motion the UK’s departure from the EU over the next two years, guaranteeing the European Medicines Agency (EMA) will see some significant changes over the next few years.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Crisis management, Drugs, Government affairs, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Brexit, EMA, MHRA, new EMA headquarters

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

CDRH Seeks Participants for Staff Training Program By Zachary Brennan - Published 24 March 2017

Medical device companies and other stakeholders have until 30 April to apply to be a part of the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) Experiential Learning Program (ELP), which is meant to help agency staffers better understand medical devices. 

Categories: News, US, CDRH, Combination products, In vitro diagnostics, Medical Devices

Tags: ELP, CDRH training, staff training FDA devices

Regulatory Recon: Alexion to Lay Off More Than 200; FDA Approves Novartis Breast Cancer Treatment (14 March 2017) By Zachary Brennan - Published 14 March 2017

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing.

Categories: News, Asia, Canada, Europe, US, DOJ, EC, EMA, FDA, Health Canada, MHRA, NICE, Biologics and biotechnology, Drugs, In vitro diagnostics, Medical Devices

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

EU Council Unanimously Adopts MDR, IVDR: Next Stop EU Parliament By Michael Mezher - Published 07 March 2017

The EU's new rules governing medical device and in vitro diagnostics (IVDs) are one step away from being fully adopted.

Categories: News, Europe, In vitro diagnostics, Medical Devices

Tags: Medical Device Regulations, MDR, In Vitro Diagnostics Regulations, IVDR, EU Council

MDR and IVDR: the Potential for a 28-Agency, 22-Language Regulatory Process for Medical Devices in the EU By Rod Ruston - Published 03 March 2017

This article provides detail in the MDR and IVDR which seems to have escaped observation. Yet, the detail could have far-reaching implications. What follows is in both the MDR and IVDR, and so in the pursuit of clarity, all references are restricted to the MDR.

Categories: Features, Europe, EC, In vitro diagnostics, Medical Devices, Submission and registration

Tags: Medical Device Regulation, In Vitro Diagnostic Medical Devices Regulation, MDR, IVDR

Final Versions of EU MDR, IVD Released, Voting Begins Next Month By Michael Mezher - Published 23 February 2017

Device manufacturers looking to abide by the EU's new medical device and in vitro diagnostic regulations take note: The EU's overhaul of its framework is here.

Categories: News, Europe, EC, In vitro diagnostics, Medical Devices

Industry Group Links More Than 28,000 Job Losses to Device Tax By Zachary Brennan - Published 08 February 2017

As part of its push to fully repeal the medical device tax from the Affordable Care Act, industry group AdvaMed took to the offensive on Wednesday, saying US medical technology jobs declined by more than 28,000 (7.2%) while the 2.3% tax was in effect.

Categories: News, US, Government affairs, In vitro diagnostics, Medical Devices

Tags: medical technology jobs, AdvaMed, device tax

MHRA Looks to Increase Medical Device Fees By Michael Mezher - Published 06 February 2017

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Monday said it will move ahead with a proposal to increase and add to the fees it charges device makers and notified bodies.

Categories: News, Europe, EC, MHRA, Clinical, In vitro diagnostics, Medical Devices

Tags: Fees, Notified Bodies

Outgoing FDA Commissioner Califf on Benefit-Risk Assessments and Advisory Committees By Zachary Brennan - Published 20 January 2017

Writing in JAMA and FDA’s Voice blog late this week, outgoing US Food and Drug Administration (FDA) commissioner Robert Califf took to task any doubters on the necessity of an independent FDA that can assess an investigational drug’s safety and efficacy.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, In vitro diagnostics, Medical Devices

Tags: Rob Califf, FDA commissioner, benefit-risk assessments, pharmaceuticals, medical devices

Asia Regulatory Roundup: China Unveils Reforms to Simplify Supply Chains, Lower Drug Costs (18 January 2017) By Nick Paul Taylor - Published 18 January 2017

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, China, India, Oceania, CDSCO, CFDA, TGA, Biologics and biotechnology, Drugs, In vitro diagnostics, Medical Devices

Tags: Asia Regulatory Roundup, Regulatory Roundup

FDA Further Explains Delay on LDT Guidance By Zachary Brennan - Published 13 January 2017

Two months after saying it would not finalize guidance on the regulation of lab-developed tests (LDTs), the US Food and Drug Administration (FDA) on Friday published a discussion paper with some hints as to how it would like the discussion and regulations on this thorny issue to move forward.

Categories: News, US, FDA, In vitro diagnostics, Medical Devices

Tags: lab-developed tests, LDTs, FDA on lab tests

FDA Finalizes Guidance on Benefit-Risk Considerations for IDEs By Michael Mezher - Published 12 January 2017

The US Food and Drug Administration (FDA) on Thursday finalized its guidance detailing its framework for assessing the benefits and risks of investigational device exemptions (IDEs).

Categories: News, US, CDRH, Clinical, In vitro diagnostics, Medical Devices

Tags: Investigational Device Exemption, Final Guidance

CDRH Lays Out Guidance Plans for FY 2017 By Zachary Brennan - Published 22 December 2016

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Thursday released a list of 12 final guidance documents and four draft guidances that it will make a priority to publish in FY 2017.

Categories: News, US, CDRH, Clinical, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: CDRH, draft guidance for medical devices, device manufacturer guidance from FDA

WHO Prequalifies First Hepatitis C Diagnostic By Zachary Brennan - Published 05 December 2016

The World Health Organization (WHO) on Monday announced it has prequalified its first hepatitis C virus (HCV) rapid diagnostic test, which will help diagnose HCV in low- and middle-income countries and potentially improve access to treatment.

Categories: News, Africa, Asia, Europe, Latin America and Caribbean, Middle East, WHO, Government affairs, In vitro diagnostics, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: WHO, prequalification, Gilead, Hepatitis C

Regulatory Explainer: 21st Century Cures Redux and What it Will Mean for FDA By Zachary Brennan - Published 28 November 2016

Lingering for more than two years, the revamped 21st Century Cures bill, unveiled in late November, has now been approved by the House and Senate and President Barack Obama has said he will sign it.

Categories: News, US, FDA, Biologics and biotechnology, Combination products, Compliance, Drugs, Government affairs, Human cell and tissue, In vitro diagnostics, Manufacturing, Medical Devices, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: 21st Century Cures, drug regulations, Congress and medical innovation, NIH, FDA innovation, Cures Now