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  • Feature ArticlesFeature Articles

    Magnetic Resonance Safety Testing and Labeling for Devices

    Traditionally, all Magnetic Resonance (MR) scanner systems have included a contraindication for patients with metallic implants. General practice was to not scan patients with implants in ordinary facilities, but only at more-sophisticated MR facilities under carefully monitored and controlled conditions. Since then, Magnetic Resonance Imaging (MRI) has become the standard of care for diagnosing many conditions, such as cancer, neurological diseases and orthopedic disord...
  • Regulatory NewsRegulatory News

    UK to Launch New Office for Market Access

    The UK's National Institute for Health and Care Excellence (NICE) is launching a new office to promote market access for innovative products through early engagement with companies. A proposal and outline for the Office for Market Access (OMA) was approved by NICE's Board of Directors on 20 May 2015. Background When a new medicine is approved in the UK, NICE is responsible for conducting a health technology assessment (HTA) to measure its cost-effectiveness and determ...
  • Regulatory NewsRegulatory News

    An Argument for Emergency Authorization During Public Health Crises

    When a public health crisis like Ebola emerges, public health officials need the flexibility to respond quickly and effectively. But as a new paper in the journal Public Library of Science - Medicine (PLoS Medicine) argues, many countries currently have in place regulatory hurdles which would delay access to experimental new emergency treatments during such crises. Background Many global healthcare product regulators have in place provisions designed to speed ac...
  • Regulatory NewsRegulatory News

    Facing Enterovirus Outbreak, HHS Gives FDA Power to Authorize Use of Experimental Diagnostics

    The US Department of Health and Human Services (DHHS) has declared that a strain of enterovirus now sweeping across the US has a high potential to cause a "public health emergency," thereby allowing the US Food and Drug Administration (FDA) to clear the use of drugs and diagnostic devices under special "emergency use" regulatory pathways. According to the US Centers for Disease Control and Prevention (CDC), the virus, known as enterovirus D68, is one of more than 100 n...
  • Regulatory NewsRegulatory News

    Senators Call for 15 Years of Marketing Exclusivity for Some New Drugs

    • 12 December 2014
    Two US senators have proposed new legislation that would grant an unprecedented 15 years of marketing exclusivity to certain types of pharmaceutical and biopharmaceutical products. Background The bill, known as the Dormant Therapies Act of 2014, is the second piece of legislation introduced in as many days by Sens. Orrin Hatch and Michael Bennet (D-CO). The duo introduced the Promise for Antibiotics and Therapeutics for Health (PATH) Act on 10 December 2014. R...
  • Regulatory NewsRegulatory News

    FDA Authorizes Sixth Device to Help in Fight Against Ebola

    The US Food and Drug Administration (FDA) has once again given its blessing to a new diagnostic tool meant to help identify treatments for Ebola—the sixth time it has used its emergency authority to do so in the last four months. Background In March 2013, FDA was given a host of new authorities and responsibilities under the  Pandemic and All-Hazards Preparedness Reauthorization Act ( PAHPRA ) , a piece of legislation intended to bolster the government's ability to ...
  • Regulatory NewsRegulatory News

    FDA Authorizes Use of New, Substantially Faster Ebola Diagnostic Tests

    The US Food and Drug Administration (FDA) has granted emergency use authorizations (EUAs) to two new diagnostic tests meant to help health professionals to accurately diagnose the Ebola Zaire virus in record time. Background In March 2013, FDA was given a host of new authorities and responsibilities under the  Pandemic and All-Hazards Preparedness Reauthorization Act  ( PAHPRA ), a piece of legislation intended to bolster the government's ability to respond to health ...
  • Regulatory NewsRegulatory News

    FDA Formally Authorizes New Diagnostic Meant to Help Fight Against Ebola

    The US Food and Drug Administration (FDA) has formally granted clearance to a testing device intended to be used to diagnose patients with the Ebola virus under special, emergency circumstances. Background In March 2013, FDA was given a host of new authorities and responsibilities under the  Pandemic and All-Hazards Preparedness Reauthorization Act ( PAHPRA ), a piece of legislation meant to bolster the government's ability to respond to health crises, and especial...
  • Regulatory NewsRegulatory News

    Pharma Company's Phone Script Violates Advertising Regulations, FDA Says

    Those who closely track so-called "Untitled Letters" authored and sent by the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) know the letters most frequently reference promotions made over two types of media: the Internet and print media. But in an unusual letter sent last week by OPDP, the office indicated that it's still keeping an eye on promotions made using a decidedly traditional format: the telephone. An Untitled Letter In i...
  • Regulatory NewsRegulatory News

    Even Pharmaceutical Marketing for Dogs can be Improper, FDA Says in Warning Letter

    When the US Food and Drug Administration (FDA) goes after pharmaceutical companies for violating federal marketing regulations, it usually goes after makers of pharmaceuticals for humans. But as a recent and rare Warning Letter illustrates, sometimes veterinary companies fall under the agency's scrutiny as well. In a 2 April 2014 letter to AB Science , a French pharmaceutical manufacturer, FDA veterinary regulators cited the company for allegedly marketing its veterinar...
  • Regulatory NewsRegulatory News

    FDA Again Exercises Rarely-Used Emergency Approval Authority

    Citing continued risks to human health, the US Food and Drug Administration (FDA) has once again granted market access for an in vitro diagnostic device meant to detect the H7N9 influenza virus, using its emergency authority under a little-known law. Background In March 2013, FDA was given a host of new authorities and responsibilities under the  Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) , a piece of legislation meant to bolster the govern...
  • Regulatory NewsRegulatory News

    China FDA Seeks Input on Draft Regulation Tightening Control of Online Drug Sales

    The China Food and Drug Administration (CFDA) has released for public consultation a draft regulation that would tighten control of online sales of food and drugs. The rule will drug prohibit producers and wholesalers to sell products to online consumers, and will require sellers of food, health food, cosmetics, and medical apparatus and instruments to obtain permits. CFDA will crack down on false advertising, and information about certain drugs, including stu...