Search Results for

Filtering on: "content types news"

Showing 1 – 25  of 4312

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 Looks Ahead and Back on Orally Inhaled and Nasal Generic Drugs By Zachary Brennan - Published 15 January 2018

The US Food and Drug Administration (FDA) has come a long way when it comes to locally acting orally inhaled and nasal drug products (OINDPs) and in the next five years of generic drug user fees, the agency is looking at further progress on some unique challenges, according to a regulatory science report on OINDPs.

Categories: News, US, FDA, Generic drugs, Regulatory intelligence, Regulatory strategy, Research and development

Tags: OINDP, locally acting orally inhaled and nasal drug products

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

FTC Settles Complaint Over Deceptive Marketing of Unapproved Cancer Products By Michael Mezher - Published 12 January 2018

The US Federal Trade Commission (FTC) on Thursday announced it has reached a settlement with CellMark Biopharma related to the company's claims about marketing efforts to sell two of its unapproved products.

Categories: News, US, FDA, FTC, Advertising and Promotion

Tags: FTC, Federal Trade Commission, CellMark

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

FDA Requires Labeling Changes for Some Cough and Cold Drugs to Better Protect Children By Zachary Brennan - Published 11 January 2018

The US Food and Drug Administration (FDA) on Thursday announced safety labeling changes for prescription cough and cold medicines containing codeine or hydrocodone as the risks of these medicines outweigh their benefits in children younger than 18.

Categories: News, US, FDA, Compliance, Crisis management, Drugs, Labeling

Tags: codeine, cough and cold, hydrocodone

ICMRA Looks to Make Track-and-Trace Systems Globally Interoperable By Zachary Brennan - Published 11 January 2018

The International Coalition of Medicines Regulatory Authorities (ICMRA) is focusing on aligning existing and planned track and trace systems worldwide, with an eye toward interoperability as many of the existing and planned systems were designed with a national or regional focus.

Categories: News, Asia, Europe, US, EMA, FDA, MHRA, Biologics and biotechnology, Crisis management, Drugs, Government affairs, Quality, Regulatory intelligence

Tags: ICMRA, track and trace, interoperability

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

Bioethicists Say Federal Right-to-Try Legislation Will Have Limited Impact on Access By Michael Mezher - Published 11 January 2018

In a perspective published in the New England Journal of Medicine on Wednesday, bioethicists Holly Fernandez Lynch and Steven Joffe of the University of Pennsylvania warn that federal "right-to-try" legislation could undermine the US Food and Drug Administration's (FDA) public health mission and will have a limited impact on improving patient access to investigational products.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Ethics

Tags: Right-to-Try, Expanded Access

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

House E&C Offers Recommendations to Improve 340B Drug Pricing Program By Zachary Brennan - Published 10 January 2018

The House Energy & Commerce (E&C) Committee on Wednesday released an 80-page report outlining issues related to the 340B drug pricing program, which helps reduce the prices of certain drugs for participating hospitals, health centers and other entities that provide care for vulnerable patients, and recommendations to improve the program’s administration.

Categories: News, US, Drugs, Government affairs, Reimbursement

Tags: HRSA, 340B, drug discount, House Energy & Commerce

EMA Adopts Guideline on Clinical Trials for Rheumatoid Arthritis Treatments By Zachary Brennan - Published 10 January 2018

The European Medicines Agency (EMA) on Wednesday announced the adoption of a guideline, first drafted in 2011, on the clinical evaluation of medicinal products in the treatment of the autoimmune disease rheumatoid arthritis (RA).

Categories: News, Europe, EMA, Biologics and biotechnology, Clinical, Drugs, Regulatory intelligence, Regulatory strategy

Tags: rheumatoid arthritis, EMA guideline

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

CDER Report on Novel Approvals Highlights Firsts in 2017 By Zachary Brennan - Published 10 January 2018

2017 was a year of firsts for the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), with initial approvals in at least five medical conditions and other firsts that might not end up on the final scorecard, like the first biosimilar cancer treatment or the first immediate-release opioid with abuse-deterrent properties.

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

Tags: 2017 novel drug approvals, CDER report, Woodcock, Gottlieb

Trial Transparency: NIH Says Final Rule From 2017 has Helped By Zachary Brennan - Published 09 January 2018

Almost a year ago, the National Institutes of Health (NIH) made effective a new policy to better disseminate information from NIH-funded clinical trials through ClinicalTrials.gov, and the agency says that so far, it’s seen some improvements.

Categories: News, US, Biologics and biotechnology, Clinical, Drugs, Research and development

Tags: NIH, clinical trial transparency, final rule, FDAAA

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

New Study Looks at FDA's Use of Social Media to Communicate on Drug Safety By Michael Mezher - Published 09 January 2018

A new study looking at the US Food and Drug Administration's (FDA) use of social media to communicate about drug safety finds that the agency could improve its impact by developing social media strategies and taking a more active role on web platforms.

Categories: News, US, FDA, Communication, Drugs

Tags: Twitter, Facebook, Social Media, Safety Communications

FDA Denies Amneal Petition Seeking to Block Generic Versions of Osteoporosis Treatment By Zachary Brennan - Published 09 January 2018

Capping a string of recent citizen petition denials, the US Food and Drug Administration (FDA) has rejected Amneal Pharmaceuticals' citizen petition asking the agency to refrain from approving any abbreviated new drug applications (ANDAs) for the blockbuster osteoporosis treatment Forteo (teriparatide).

Categories: News, US, FDA, Biologics and biotechnology, Generic drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: Forteo, osteoporosis, Amneal, Lilly, citizen petitions