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Filtering on: "topics medical devices"

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Regulatory Recon: FDA Approves Tesaro's Zejula for Ovarian Cancer; Trump Pushes Congress to Cut NIH 2017 Budget (28 March 2017) By Michael Mezher - Published 28 March 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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

FDA Office of Regulatory Affairs Realignment to Begin in May By Michael Mezher - Published 28 March 2017

The US Food and Drug Administration's (FDA) Office of Regulatory Affairs (ORA), which carries out the agency's inspection program, will officially begin a major overhaul in the coming weeks, according to FDA's Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren.

Categories: News, US, FDA, Compliance, Medical Devices

Tags: Office of Regulatory Affairs, Inspections, Jeffrey Shuren, House Energy & Commerce

Regulatory Recon: AZ's Tagrisso First to be Approved Under China's Priority Review Pathway; House Hearing on Device User Fees Set for Tuesday (27 March 2017) By Michael Mezher - Published 27 March 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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

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

Regulatory Recon: House Vote on Healthcare Bill Set for Friday Afternoon; Pfizer, German Merck mAb Gets First Approval for MCC (24 March 2017) By Michael Mezher - Published 24 March 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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

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: Fate of Health Care Act Uncertain as Vote Nears; GSK and Regeneron in Deal to Sequence Genes of 500,000 Britons (23 March 2017) By Michael Mezher - Published 23 March 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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

Regulatory Recon: FDA Approves Newron's  Xadago as Add-On for Parkinson's Disease; Novartis Heart Drug Serelaxin Fails in Phase III Trial (22 March 2017) By Michael Mezher - Published 22 March 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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

When to Submit a 510(k) (Devices and Software): A Regulatory Perspective By Jeff Ryberg - Published 21 March 2017

This article explores key elements of the US Food and Drug Administration's (FDA's) latest draft guidance to industry for deciding when to submit a new 510(k) for medical device hardware and software design changes. The potential business impact is assessed and suggestions are provided for what companies need to do to align with FDA's current thinking.

Categories: Features, US, FDA, Medical Devices, Submission and registration

Tags: 510(k), Software

FDA Concurs With WHO on Rare Lymphoma Linked to Breast Implants By Zachary Brennan - Published 21 March 2017

The US Food and Drug Administration (FDA) on Tuesday said it now concurs with the World Health Organization’s designation of an association between breast implants and the development of anaplastic large cell lymphoma (ALCL), a rare type of non-Hodgkin's lymphoma.

Categories: News, US, FDA, TGA, WHO, Compliance, Medical Devices, Quality, Regulatory intelligence, Regulatory strategy

Tags: breast implants, lymphoma, BIA-ALCL

Regulatory Recon: Array Withdraws Binimetinib Application Ahead of Advisory Committee; Amgen Submits Herceptin Biosimilar for EU Approval (21 March 2017) By Michael Mezher - Published 21 March 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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

CDER, CDRH and CBER Directors Stress Importance of User Fee Reauthorizations Before Senate Committee By Zachary Brennan - Published 21 March 2017

The US Senate Health, Education, Labor & Pensions Committee on Tuesday pressed three top US Food and Drug Administration (FDA) officials for details on how plans to reauthorize their user fee programs would help to further streamline medical product approvals.

Categories: News, US, CBER, CDER, CDRH, Biologics and biotechnology, Drugs, Government affairs, Medical Devices

Tags: FDA user fees, GDUFA, BsUFA, MDUFA, PDUFA, Senate HELP

Regulatory Recon: China Looks to Speed Approvals for Imported Drugs; Highlights from ACC17 (20 March 2017) By Michael Mezher - Published 20 March 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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

FDA Delays Final Rule on Intended Uses By Michael Mezher - Published 17 March 2017

The US Food and Drug Administration (FDA) on Friday announced it will delay implementation of its final rule clarifying when tobacco products are regulated as medical products until March 2018 in response to a petition from biopharmaceutical industry groups that raised questions about how the rule would alter the agency's definition of intended uses for drugs and medical devices.

Categories: News, US, FDA, Biologics and biotechnology, Communication, Drugs, Medical Devices

Tags: Intended Use, Final Rule, Totality of Evidence

Regulatory Recon: Amgen Cholesterol Drug Data Disappoints Investors; German Drugmaker Stada Stokes Private Equity Bidding War (17 March 2017) By Michael Mezher - Published 17 March 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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

Trump FY 2018 Budget Blueprint: Hike in FDA User Fees? By Zachary Brennan - Published 16 March 2017

President Donald Trump’s administration released its budget blueprint for FY 2018 on Thursday, calling for a hike in user fees from industry to make up for cuts elsewhere at the US Food and Drug Administration (FDA).

Categories: News, US, DOJ, FDA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Trump budget, FDA budget 2018, user fees, user fee reauthorization

Regulatory Recon: PTC to Buy Marathon's Emflaza; NICE Cleared to Fast Track More Approvals (16 March 2017) By Michael Mezher - Published 16 March 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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

MHRA Releases Recommendations for Leadless Pacemakers By Michael Mezher - Published 16 March 2017

The UK's Medicines and Healthcare products Regulatory Agency's expert advisory group on leadless cardiac devices has released its initial recommendations for pre- and postmarket clinical studies for leadless pacemakers.

Categories: News, Europe, MHRA, Clinical, Medical Devices, Postmarket surveillance

Tags: Leadless Pacemakers

Regulatory Recon: Merck's Keytruda Gets FDA Nod for Hodgkin Lymphoma; FDA Panel Says Opana Risks Outweigh Benefits (15 March 2017) By Michael Mezher - Published 15 March 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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

Asia Regulatory Roundup: Pfizer Asks TGA to Rethink Timeline for Biologics AE Reporting (14 March 2017) By Nick Paul Taylor - Published 14 March 2017

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

Categories: News, Asia, CDSCO, TGA, Biologics and biotechnology, Drugs, Medical Devices

Tags: Asia Regulatory Roundup, Pfizer, NPPA, stents

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

FDA Considers Creating New 'Office of Patient Affairs' By Zachary Brennan - Published 13 March 2017

As part of efforts to better capture patients' perspectives, the US Food and Drug Administration (FDA) on Monday said it is considering establishing an "Office of Patient Affairs," to be tasked with supporting and coordinating patient engagement across the agency.

Categories: News, FDA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices

Tags: patient engagement and FDA, PEAC, patient perspectives, FDA patient advice

Regulatory Recon: Roche and Mylan Settle Dispute Over Herceptin Biosimilar; EMA Suspends Marketing of Four Contrast Agents for MRI Images (13 March 2017) By Zachary Brennan - Published 13 March 2017

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

Categories: News, Canada, Europe, US, EMA, FDA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices

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

FDA Drafts List of Class II Devices to be Exempt From Premarket Notification By Zachary Brennan - Published 13 March 2017

The US Food and Drug Administration (FDA) began implementing the recently passed 21st Century Cures Act on Monday by publishing a draft list of class II devices that will be exempt from premarket notification requirements, or 510(k)s.

Categories: News, US, CDRH, Compliance, Due Diligence, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Class II devices, 21st Century Cures, FD&C Act

Regulatory Recon: Results From CRISPR Gene Editing of Embryos (10 March 2017) By Zachary Brennan - Published 10 March 2017

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

Categories: News, Asia, Europe, US, EMA, FDA, Biologics and biotechnology, Drugs, Medical Devices

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