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  • Regulatory NewsRegulatory News

    EMA Looks to Accelerate New Therapies Targeting Unmet Needs

    The European Medicines Agency (EMA) on Monday launched its new PRIME (PRIority MEdicines) scheme which aims to streamline the development of promising new therapies that meet unmet medical needs. Like the breakthrough therapy program in the US, the new EMA program aims to accelerate the development of new drugs to treat rare cancers, Alzheimer's and other neurodegenerative diseases, AIDS and diabetes, among others. "I think we still see too many patients in desperate n...
  • Regulatory NewsRegulatory News

    Updated: UK Company Banned From Shipping Medical Devices to US

    [ Editor's note from 2/25/16: This article has been updated with comment from Bedfont. ] The US Food and Drug Administration (FDA) has added UK-based Bedfont Scientific to its import alert list for medical device companies that have not met device quality system requirements. Bedfont is now banned from shipping its products to the US, which includes its breath test monitors, nitric oxide and carbon monoxide monitors, and medical pipeline testing equipment. “Foreign ...
  • Feature ArticlesFeature Articles

    Scientific Advice Meetings With Health Canada

    Types of Meetings With Health Canada Meetings with Health Canada are similar to US Food and Drug Administration (FDA) meetings or Scientific Advice meetings with either the European Medicines Agency (EMA) or individual EU Member States. A meeting request is submitted with questions to provide some background to introduce the agency to the company’s development program and establish why the meeting is needed. Once a meeting date has been set, the company sends a meeting p...
  • Regulatory NewsRegulatory News

    EMA in 2014: A Landmark Year for Approvals, With Eyes on the Future

    In the European Medicines Agency's (EMA) Annual Report 2014 , top regulatory officials describe the agency's role as both a "gatekeeper" and "enabler." This dual role means that the agency must not only work to ensure the safety of patients in the EU, but also to facilitate the development of new and innovative therapies. By the Numbers 2014 was a landmark year for EMA in many ways. The agency recommended record numbers of products to treat rare diseases , launched it...
  • Regulatory NewsRegulatory News

    EMA Says Complying With its Scientific Advice Raises Likelihood of Approval, Fewer Objections

    A new study authored by European Medicines Agency (EMA) staff finds that companies that followed the agency's scientific advice are more likely to get their products authorized . Background EMA provides scientific advice to companies for a fee in order to assist them in designing clinical trials through its Scientific Advice Working Party (SAWP). If a clinical trial is not well designed, it can be difficult to for the agency to conduct an assessment of the product a...
  • Regulatory NewsRegulatory News

    The Key to EU Market Access for Pharmaceutical Companies: Early Engagement

    The path to regulatory approval can be long and arduous. It can also be especially difficult for smaller companies to navigate. But a new report finds that early input from health authorities can help make the process more straightforward. The report is based on information gathered through interviews with small- and medium-sized biotechnology companies, the European Medicines Agency (EMA) and HTA bodies. The report finds early engagement with regulatory authorities an...
  • Regulatory NewsRegulatory News

    Boston Scientific Ordered to Pay Surgical Costs for Faulty Pacemakers

    A prominent European court has ruled that Boston Scientific’s German branch is responsible for paying the surgical costs associated with replacing faulty implantable devices made by one of the company’s subsidiaries. In 2005, Guidant Corporation – which was acquired by Boston Scientific in 2006 – informed doctors it had identified potentially faulty components in three of its implantable products, two pacemakers and an implantable cardioverter defibrillator. Main Proc...
  • Regulatory NewsRegulatory News

    EMA Boasts Success of Tools for Small- and Medium-Sized Companies

    The European Medicines Agency (EMA) says that its tools designed to aid micro-, small- and medium-sized enterprises (SMEs) have increased those companies’ success in obtaining authorization for their products. The agency released a report this week highlighting the growth and success of the program. Background The European Commission (EC) found that a number of hurdles, including procedural and financial steps involved in obtaining marketing authorization, heavily aff...
  • Regulatory NewsRegulatory News

    FDA to Provide Guidance on Use of Economic Information, Responses to Unsolicited Requests

    US regulators are planning to release several additional guidance documents by the end of the year relating to scientific exchanges of information and other promotional-like activities, including a long-awaited guidance document on the use of healthcare economic information. Background The US Food and Drug Administration (FDA) recently released two draft guidance documents intended to clarify how it treats scientific and medical literature. The first of those guida...
  • Regulatory NewsRegulatory News

    Legal Group to FDA: Reprint Guidance Violates First Amendment, Existing Court Order

    Public comments submitted to the US Food and Drug Administration (FDA) regarding its guidance documents are generally tame, referring to matters for preference or a need to clarify vague sections. But in the case of a recent response to a new guidance on distributing reprints of scientific and medical literature, one group's message for FDA is a bit more confrontational: Make changes to the guidance— or else . Background In February 2014, FDA released a new draft guida...
  • EU’s Scientific Committees to Look at Synthetic Biology

    The European Commission's three Scientific Committees have been requested to provide a joint scientific opinion on the relationship of Synthetic Biology (SB) to genetic modification of organisms, its implications for human and animal health and the environment, and the major gaps in knowledge necessary for performing a reliable risk assessment. Synthetic Biology is the term used to describe the creation of biological systems that do not exist in nature using engineeri...
  • EMA Announces Huge Overhaul of Operations, Processes

    The European Medicines Agency (EMA) is preparing to reorganize its operations, processes and offices in 2013, it has announced. In a statement released on its website on 19 December 2012, the agency said the overhaul will be "focused on increasing the efficiency of its scientific activities and information- and communication-technology operations." A particular focus will be placed on how it supports the mission of its scientific committees-the Committee for Medicinal P...