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Filtering on: "topics medical devices"

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Regulatory Recon: Google Backs UK Universal Vaccine Company; Shire Wins EU Approval for Long Acting Hemophilia A Treatment (15 January 2018) By Michael Mezher - Published 15 January 2018

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 Details New Manufacturing Quality Pilot Program By Michael Mezher - Published 15 January 2018

The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) last month released details on its upcoming voluntary medical device manufacturing and product quality pilot program as part of its Case for Quality (CfQ) initiative.

Categories: News, US, FDA, Manufacturing, Medical Devices, Quality

Tags: Case for Quality, Pilot

Markey and Warren Re-Intro Bill to Repeal Medical Device Tax By Zachary Brennan - Published 15 January 2018

Sens. Ed Markey (D-MA) and Elizabeth Warren (D-MA) re-introduced a bill from 2015 last week that would permanently repeal a 2.3% medical device tax that was delayed for two years but took effect at the beginning of this year.

Categories: News, US, Government affairs, Medical Devices

Tags: Elizabeth Warren, medical device tax

FDA Warns BD Over Changes Made to Blood Collection Tubes in Lead Testing Investigation By Michael Mezher - Published 12 January 2018

After launching an investigation into the root cause of false lead test results from four of Magellan Diagnostics' LeadCare testing systems last May, the US Food and Drug Administration (FDA) on Thursday warned Becton Dickinson (BD) for failing to submit a new 510(k) for changes to its blood collection tubes.

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

Tags: BD, LeadCare, Magellan Diagnostics, Vacutainer, Warning Letter

Regulatory Recon: FDA Approves AZ's Lynparza to Treat Breast Cancer with BRCA Mutation; Roche's MS Drug Ocrevus Wins EU Approval (12 January 2018) By Michael Mezher - Published 12 January 2018

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 Implementing Parts of 'Intended Use' Rule By Zachary Brennan - Published 12 January 2018

Confusion and concerns over portions of a tobacco-related final rule that could have major ramifications for the medical product industries has pushed the US Food and Drug Administration (FDA) to delay the sections dealing with the types of evidence FDA may consider to determine how a manufacturer intends for its medical product to be used.

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

Tags: intended use, First Amendment, FDA rule

FDA Pushes Back Enforcement of UDI Requirements for Class I, Unclassified Devices By Zachary Brennan - Published 12 January 2018

The US Food and Drug Administration (FDA) said Friday that it will delay its enforcement of certain unique device identification (UDI) system requirements for class I and unclassified devices by two years.

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

Tags: unique device identification, Class I, unclassified devices, UDI enforcement

Regulatory Recon: FDA Panel Votes Against Testosterone Therapies; Endo Subpoenaed for Opioid Information (11 January 2018) By Michael Mezher - Published 11 January 2018

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

European Regulatory Roundup: Swissmedic Updates Biosimilar Guidance (11 January 2018) By Nick Paul Taylor - Published 11 January 2018

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Medical Devices

Tags: European Regulatory Roundup, Swissmedic, biosimilars, multi-dose containers

FDA Plots Policy Priorities for 2018 By Zachary Brennan - Published 11 January 2018

The US Food and Drug Administration (FDA) on Thursday announced its priorities for policy activity in 2018, which will include reducing the misuse and abuse of opioids, promoting generic drug and biosimilar competition, creating a total product lifecycle office for medical devices, advancing digital health technologies and strengthening the agency’s workforce.

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

Tags: generic competition, total product lifecycle, opioids

FDA Warns Doctors of Collapsed Lungs and Deaths Possibly Linked to Feeding Tube Placement Devices By Zachary Brennan - Published 11 January 2018

The US Food and Drug Administration (FDA) on Thursday sent a letter to health care providers to provide information about reports of pneumothorax events, or collapsed lungs, and deaths associated with feeding tube placement procedures using some enteral access systems (EAS).

Categories: News, US, FDA, Crisis management, Due Diligence, Government affairs, Medical Devices

Tags: feeding tubes, EAS, collapsed lung

Device Recalls in 2017: Making Sense of the Numbers By Michael Mezher - Published 10 January 2018

Each year, the US Food and Drug Administration (FDA) designates anywhere from dozen to hundreds of medical device recalls as Class I, indicating that the risk addressed by the recall could potentially cause serious injury or death.

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

Tags: Recalls, Corrections, Removals, Class I Recall

Regulatory Recon: Bluebird Planning for First Three Approvals by 2019; EU Approves Vertex' Orkambi for Younger Patients (10 January 2018) By Michael Mezher - Published 10 January 2018

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: Lilly CEO Says Tax Reform May Boost Pharma Deal Making; 50 Top Managers Replaced at GSK in Walmsley's 1st Year (9 January 2018) By Michael Mezher - Published 09 January 2018

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

Barriers to FDA and CMS Parallel Reviews: Fear and Bandwidth, Shuren Says By Zachary Brennan - Published 09 January 2018

Medical device companies should want to streamline the process of getting their products reviewed simultaneously by the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and Centers for Medicare and Medicaid Services (CMS) - so why aren’t they?

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

Tags: parallel review, Shuren, MOU

Asia Regulatory Roundup: China Posts Guiding Principles on Device Trials (9 January 2018) By Nick Paul Taylor - Published 09 January 2018

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, Medical Devices

Tags: Asia Regulatory Roundup, dengue vaccine, Sanofi, device inspections

European Commission Updates Borderline Device Classification Manual By Michael Mezher - Published 08 January 2018

The European Commission (EC) last week released an update to its manual on classifying "borderline" medical devices featuring clarifications as to the medical device status and classification of on twelve additional types of products.

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

Tags: Borderline Products, MDR, IVDR

Regulatory Recon: Celgene to Buy Impact Biomedicines for Up to $7B; Ablynx Rejects Novo's $3.1B Bid (8 January 2018) By Michael Mezher - Published 08 January 2018

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 Expands Use of Amgen's Fracture Prevention Drug Xgeva; Takeda Signs Alzheimer's Pact With Denali, Strikes Deal to Acquire TiGenix (5 January 2018) By Michael Mezher - Published 05 January 2018

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: Pfizer Signs $830M Discovery Pact with Arvinas; Philippines Fines Sanofi, Pulls Dengvaxia Registration (4 January 2018) By Michael Mezher - Published 04 January 2018

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: Spark Prices Gene Therapy at $850,000; WHO Prequalifies Typhoid Vaccine (3 January 2018) By Michael Mezher - Published 03 January 2018

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: Biopharma and Legislative Questions for 2018 (2 January 2018) By Zachary Brennan - Published 02 January 2018

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

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

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

Asia Regulatory Roundup: TGA Adopts Guidance on Device Priority Review Pathway (2 January 2018) By Nick Paul Taylor - Published 02 January 2018

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, Medical Devices

Tags: Asia Regulatory Roundup, device priority reviews, overseas regulators

Regulatory Strategies for OTC Switch Programs, Implementing EU MDR & IVDR and a Preview of January By Gloria Hall - Published 22 December 2017

Feature articles over the past several weeks provided background, approaches, regulatory considerations, and strategies for implementing prescription to Over-the-Counter (Rx-to-OTC) switch programs; CE marking requirements of IVD medical devices under the new EU regulation; explanation of Annex I general requirements and essential requirements; implementation strategies for the new EU medical devices regulations; and medical device classification rules, manufacturer registration procedures, dossier filing procedures, and pre-clinical and marketing application approval processes in India.

Categories: Features, India, Europe, US, Clinical, Over the counter drugs, Prescription drugs, In vitro diagnostics, Medical Devices

Tags: Feature Editorial

FDA Lays Out Plans for Summary Device Malfunction Reporting By Michael Mezher - Published 22 December 2017

The US Food and Drug Administration (FDA) on Friday released a proposal that would allow medical device manufacturers to submit malfunction reports for certain devices to the agency in summary format on a quarterly basis.

Categories: News, US, FDA, Medical Devices, Postmarket surveillance

Tags: Malfunction, Medical Device Reporting, MDR